MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2016-11-21 for IMPRA VASCULAR GRAFT UNKNOWN GRAFT manufactured by Bard Peripheral Vascular, Inc..
[60620970]
No medical records or no images have been made available to the manufacturer. As the lot number for the device has not been provided, a review of the device history records could not be performed. The device has not been returned to the manufacturer for evaluation. An investigation of the reported event is currently underway. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[60620971]
It was reported that during a clinical trial procedure, after approximately fifty three days post-operative graft implantation in the left upper arm, the patient presented to the emergency room (er) with alleged fever and was diagnosed with sepsis infection, requiring hospitalization. It was further reported that there was no action taken with the graft in response to the event. The health care provider (hcp) commenced treatment with levaquin which was later switched to gentamycin and vancomycin. New information: it was reported that after approximately fifty six days post-operative graft implantation in the left upper arm, the patient presented alleged fever, chills, and abdominal cramping. It was further reported that after experiencing these symptoms for forty eight hours, the patient presented to the emergency room (er), was diagnosed with sepsis, and was hospitalized. Reportedly, the patient was commenced on levaquin, gentamycin, and vancomycin, which were switched to ceftriaxone as recommended by the infectious disease physician. The patient was discharged from the hospital approximately three days after with a prescription to continue ceftriaxone, and a transesophageal echocardiogram (tee) was scheduled.
Patient Sequence No: 1, Text Type: D, B5
[62829930]
Manufacturing review: a manufacturing review could not be performed, as the lot number was not provided. Visual inspection: the sample was not returned; therefore, visual inspection could not be performed. Functional/performance evaluation: the sample was not returned; therefore, functional/performance evaluation could not be performed. Medical records were not provided; therefore, a review could not be performed. Image/photo review: images/photos were not provided; therefore, a review could not be performed. Conclusion: the device was not returned. Images and medical records were not provided. There was no specific deficiency alleged. The investigation is inconclusive. The root cause could not be determined based upon available information. It was unknown whether procedural factors contributed to the event. Labeling review: the current instruction for use (ifu) states: adverse reactions potential complications which may occur with any surgical procedure involving a vascular prosthesis include, but are not limited to: -disruption or tearing of the suture line graft, and/or host vessel; suture hole bleeding; graft redundancy; thrombosis, embolic events, occlusion or stenosis; ultrafiltration; seroma formation; swelling of the implanted limb; formation of hematoma or pseudoaneurysm; infection; aneurysm/dilation; blood leakage; hemorrhage; steal syndrome; and/or skin erosion. Date received by mfr. (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[62829931]
It was reported that during a clinical trial procedure, after approximately fifty three days post-operative graft implantation in the left upper arm, the patient presented to the emergency room (er) with alleged fever and was diagnosed with sepsis infection, requiring hospitalization. It was further reported that there was no action taken with the graft in response to the event. The health care provider (hcp) commenced treatment with levaquin which was later switched to gentamycin and vancomycin. New information: it was reported that after approximately fifty six days post-operative graft implantation in the left upper arm, the patient presented alleged fever, chills, and abdominal cramping. It was further reported that after experiencing these symptoms for forty eight hours, the patient presented to the emergency room (er), was diagnosed with sepsis, and was hospitalized. Reportedly, the patient was commenced on levaquin, gentamycin, and vancomycin, which were switched to ceftriaxone as recommended by the infectious disease physician. The patient was discharged from the hospital approximately three days after with a prescription to continue ceftriaxone, and a transesophageal echocardiogram (tee) was scheduled.
Patient Sequence No: 1, Text Type: D, B5
[64142747]
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: as medical images were not provided, a review could not be performed. Clinical trial review: the subject was enrolled in a phase 3 comparison of hav and ptfe grafts as conduits for hemodialysis in patients needing renal replacement therapy. Approximately six days after enrollment in the clinical trial, the subject had a study conduit placed in the left upper arm. Approximately fifty-six days post insertion of the study conduit, the subject developed symptoms including fever, chills and abdominal cramping. Two days post onset of symptoms, the subject presented to the emergency department and was diagnosed with moderate sepsis. Diagnostics included chest x-ray, electrocardiogram, transesophageal electrocardiogram and laboratory tests and treatment included the use of broad-spectrum antibiotics. The subject was discharged home three days post hospital admission. Approximately nineteen days post onset of symptoms, the sepsis was considered resolved and the antibiotics were completed. Conclusion: the device was not returned. Images and medical records were not provided. There was no specific deficiency alleged. The investigation is inconclusive. The root cause could not be determined based upon available information. It is unknown whether procedural factors contributed to the event. Labeling review: the current instruction for use (ifu) states: adverse reactions potential complications which may occur with any surgical procedure involving a vascular prosthesis include, but are not limited to: -disruption or tearing of the suture line graft, and/or host vessel; suture hole bleeding; graft redundancy; thrombosis, embolic events, occlusion or stenosis; ultrafiltration; seroma formation; swelling of the implanted limb; formation of hematoma or pseudoaneurysm; infection; aneurysm/dilation; blood leakage; hemorrhage; steal syndrome; and/or skin erosion. (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[64142748]
It was reported that during a clinical trial procedure, after approximately fifty three days post-operative graft implantation in the left upper arm, the patient presented to the emergency room (er) with alleged fever and was diagnosed with sepsis infection, requiring hospitalization. It was further reported that there was no action taken with the graft in response to the event. The health care provider (hcp) commenced treatment with levaquin which was later switched to gentamycin and vancomycin. New information: it was reported that after approximately fifty six days post-operative graft implantation in the left upper arm, the patient presented alleged fever, chills, and abdominal cramping. It was further reported that after experiencing these symptoms for forty eight hours, the patient presented to the emergency room (er), was diagnosed with sepsis, and was hospitalized. Reportedly, the patient was commenced on levaquin, gentamycin, and vancomycin, which were switched to ceftriaxone as recommended by the infectious disease physician. The patient was discharged from the hospital approximately three days after with a prescription to continue ceftriaxone, and a transesophageal echocardiogram (tee) was scheduled. New information received: it was reported through the results of a clinical trial, the subject had a graft implanted in the left upper arm. Approximately fifty-six days post graft insertion, the subject developed symptoms of fever, chills and abdominal cramping. Two days post onset of symptoms, the subject was diagnosed with moderate sepsis and admitted to the hospital. The course of treatment included broad-spectrum antibiotics. The subject was discharged home three days post hospital admission with a prescription to continue antibiotics. Approximately nineteen days post onset of symptoms, the sepsis was considered resolved and the antibiotics were completed.
Patient Sequence No: 1, Text Type: D, B5
[70475739]
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: as medical images were not provided, a review could not be performed. Clinical trial review: the subject was enrolled in a phase 3 comparison of hav and ptfe grafts as conduits for hemodialysis in patients needing renal replacement therapy. Approximately six days after enrollment in the clinical trial, the subject had a study conduit placed in the left upper arm. Approximately fifty-six days post insertion of the study conduit, the subject developed symptoms including fever, chills and abdominal cramping. Two days post onset of symptoms, the subject presented to the emergency department and was diagnosed with moderate sepsis. Diagnostics included chest x-ray, electrocardiogram, transesophageal electrocardiogram and laboratory tests and treatment included the use of broad-spectrum antibiotics. During the hospitalization, the study conduit was reported as fine with no redness, swelling, masses or tenderness. No intra-abdominal process was identified and the abdominal cramping resolved without specific treatment. The subject was discharged home three days post hospital admission. Approximately nineteen days post onset of symptoms, the sepsis was considered resolved and the antibiotics were completed. Conclusion: the device was not returned. Images and medical records were not provided. There was no specific deficiency alleged. The investigation is inconclusive. The root cause could not be determined based upon available information. It is unknown whether procedural factors contributed to the event. Labeling review: the current instruction for use (ifu) states: adverse reactions: potential complications which may occur with any surgical procedure involving a vascular prosthesis include, but are not limited to: disruption or tearing of the suture line graft, and/or host vessel; suture hole bleeding; graft redundancy; thrombosis, embolic events, occlusion or stenosis; ultrafiltration; seroma formation; swelling of the implanted limb; formation of hematoma or pseudoaneurysm; infection; aneurysm/dilation; blood leakage; hemorrhage; steal syndrome; and/or skin erosion. (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[70475740]
It was reported that during a clinical trial procedure, after approximately fifty three days post-operative graft implantation in the left upper arm, the patient presented to the emergency room (er) with alleged fever and was diagnosed with sepsis infection, requiring hospitalization. It was further reported that there was no action taken with the graft in response to the event. The health care provider (hcp) commenced treatment with levaquin which was later switched to gentamycin and vancomycin. New information: it was reported that after approximately fifty six days post-operative graft implantation in the left upper arm, the patient presented alleged fever, chills, and abdominal cramping. It was further reported that after experiencing these symptoms for forty eight hours, the patient presented to the emergency room (er), was diagnosed with sepsis, and was hospitalized. Reportedly, the patient was commenced on levaquin, gentamycin, and vancomycin, which were switched to ceftriaxone as recommended by the infectious disease physician. The patient was discharged from the hospital approximately three days after with a prescription to continue ceftriaxone, and a transesophageal echocardiogram (tee) was scheduled. New information received: it was reported through the results of a clinical trial, the subject had a graft implanted in the left upper arm. Approximately fifty-six days post graft insertion, the subject developed symptoms of fever, chills and abdominal cramping. Two days post onset of symptoms, the subject was diagnosed with moderate sepsis and admitted to the hospital. The course of treatment included broad-spectrum antibiotics. The subject was discharged home three days post hospital admission with a prescription to continue antibiotics. Approximately nineteen days post onset of symptoms, the sepsis was considered resolved and the antibiotics were completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-01098 |
| MDR Report Key | 6119097 |
| Report Source | HEALTH PROFESSIONAL,STUDY,USE |
| Date Received | 2016-11-21 |
| Date of Report | 2016-10-31 |
| Date of Event | 2016-10-23 |
| Date Mfgr Received | 2017-03-09 |
| Date Added to Maude | 2016-11-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPRA VASCULAR GRAFT |
| Generic Name | EPTFE VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2016-11-21 |
| Catalog Number | UNKNOWN GRAFT |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2016-11-21 |