MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-13 for IMPRA VASCULAR GRAFTS 40S06 manufactured by Bard Peripheral Vascular, Inc..
[57400558]
Manufacturing review: a manufacturing review could not be conducted as the lot number is unknown. 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 review: 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 for evaluation. Images and medical records were not provided for review. The investigation is inconclusive for the reported leak in the vascular graft. The definitive root cause could not be determined based upon available information. It is unknown whether patient and/or procedural issues contributed to the event. Labeling/review: the current instruction for use (ifu) states: warnings: aggressive and/or excessive graft manipulation when tunneling, or placement within a too tight or too small tunnel, may lead to separation of the spiral beading and/or graft breakage. Avoid repeated or excessive clamping at the same location on the graft. If clamping is necessary, use only atraumatic or appropriate vascular smooth jawed clamps to avoid damage to the graft wall. Exposure to solutions (e. G. , alcohol, oil, aqueous solutions, etc. ) may result in loss of the graft? S hydrophobic properties. Loss of the hydrophobic barrier may result in graft wall leakage. Preclotting of this graft is unnecessary. Avoid excessive graft manipulation after exposure to blood or body fluids. Do not forcibly inject any solution through the lumen of the graft, or fill the graft with fluid prior to pulling it through the tunnel as loss of the graft? S hydrophobic properties may occur. Loss of the hydrophobic barrier may result in graft wall leakage. 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
[57400559]
It was reported that thirteen days post-operative procedure of a right upper arm vascular graft, the patient allegedly presented with a seroma with drainage from the graft at the antecubital fossa side and was admitted to the hospital. The health care provider (hcp) repaired the arteriovenous graft and performed excision of the seroma. The patient reportedly tolerated the procedure well and was discharged the following day. The event was considered resolved on the date of hospital discharge.
Patient Sequence No: 1, Text Type: D, B5
[60110554]
Manufacturing review: a manufacturing review could not be conducted as the lot number is unknown. 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 review: medical records were received and reviewed. Nine days post implantation of the av graft, the patient presented with drainage from a seroma located at the site of the surgical incisions. The patient was admitted to the hospital and given 5000 units of heparin, subcutaneously, every eight hours. The following day the seroma was opened, irrigated with heparin solution and closed. The patient was discharged from the hospital following the drainage procedure. Image/photo review: images/photos were not provided; therefore, a review could not be performed. Conclusion: the device was not returned for evaluation. Images not provided for review. Medical records were provided and reviewed. Nine days post implantation of the av graft, the patient presented with drainage from a seroma located at the site of the surgical incisions. The patient was admitted to the hospital and given 5000 units of heparin, subcutaneously, every eight hours. The following day the seroma was opened, irrigated with heparin solution and closed. Based on the medical records, the investigation is inconclusive for a leak in the graft. The formation of the seroma and the grafts relationship to its formation is unknown. The definitive root cause could not be determined based upon available information. It is unknown whether patient and/or procedural issues contributed to the event. Labeling/review: the current instruction for use (ifu) states: warnings: aggressive and/or excessive graft manipulation when tunneling, or placement within a too tight or too small tunnel, may lead to separation of the spiral beading and/or graft breakage. Avoid repeated or excessive clamping at the same location on the graft. If clamping is necessary, use only atraumatic or appropriate vascular smooth jawed clamps to avoid damage to the graft wall. Exposure to solutions (e. G. , alcohol, oil, aqueous solutions, etc. ) may result in loss of the graft's hydrophobic properties. Loss of the hydrophobic barrier may result in graft wall leakage. Preclotting of this graft is unnecessary. Avoid excessive graft manipulation after exposure to blood or body fluids. Do not forcibly inject any solution through the lumen of the graft, or fill the graft with fluid prior to pulling it through the tunnel as loss of the graft's hydrophobic properties may occur. Loss of the hydrophobic barrier may result in graft wall leakage. Describe event or problem, other relevant history, report source. Additional event information: 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
[60110555]
It was reported that thirteen days post-operative procedure of a right upper arm vascular graft, the patient allegedly presented with a seroma with drainage from the graft at the antecubital fossa side and was admitted to the hospital. The health care provider (hcp) repaired the arteriovenous graft and performed excision of the seroma. The patient reportedly tolerated the procedure well and was discharged the following day. The event was considered resolved on the date of hospital discharge. New information: received and reviewed medical records. Nine days post surgical implant of an av graft the patient presented with drainage from a seroma (fluid collection under the skin) located at the site of the surgical incision. The patient was admitted to the hospital and given 5000 units of heparin, subcutaneously, every eight hours. The following day the seroma was opened, irrigated with heparin solution and closed. The patient was discharged from the hospital following the drainage procedure. New information it was reported that approximately sixty two days after the patient had been implanted with a surgical graft, the patient experienced an alleged (unspecified) infection requiring hospitalization. No other information has been provided at this time, this file will be updated further if more information is provided.
Patient Sequence No: 1, Text Type: D, B5
[65856633]
Manufacturing review: a manufacturing review could not be conducted as the lot number was unknown. 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 review: medical records were received and reviewed. Nine days post implantation of the av graft, the patient presented with drainage from a seroma located at the site of the surgical incisions. The patient was admitted to the hospital and given 5000 units of heparin, subcutaneously, every eight hours. The following day the seroma was opened, irrigated with heparin solution and closed. The patient was discharged from the hospital following the drainage procedure. Image/photo review: images/photos were not provided; therefore, a review could not be performed. Conclusion: the device was not returned for evaluation. Images not provided for review. Medical records were provided and reviewed. Nine days post implantation of the av graft, the patient presented with drainage from a seroma located at the site of the surgical incisions. The patient was admitted to the hospital and given 5000 units of heparin, subcutaneously, every eight hours. The following day the seroma was opened, irrigated with heparin solution and closed. Based on the medical records, the investigation was inconclusive for a leak in the graft. The formation of the seroma and the grafts relationship to its formation is unknown. The definitive root cause could not be determined based upon available information. It was unknown whether patient and/or procedural issues contributed to the event. Labeling/review: the current instruction for use (ifu) states: warnings: aggressive and/or excessive graft manipulation when tunneling, or placement within a too tight or too small tunnel, may lead to separation of the spiral beading and/or graft breakage. Avoid repeated or excessive clamping at the same location on the graft. If clamping is necessary, use only atraumatic or appropriate vascular smooth jawed clamps to avoid damage to the graft wall. Exposure to solutions (e. G. , alcohol, oil, aqueous solutions, etc. ) may result in loss of the graft? S hydrophobic properties. Loss of the hydrophobic barrier may result in graft wall leakage. Preclotting of this graft is unnecessary. Avoid excessive graft manipulation after exposure to blood or body fluids. Do not forcibly inject any solution through the lumen of the graft, or fill the graft with fluid prior to pulling it through the tunnel as loss of the graft? S hydrophobic properties may occur. Loss of the hydrophobic barrier may result in graft wall leakage. (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
[65856634]
It was reported that thirteen days post-operative procedure of a right upper arm vascular graft, the patient allegedly presented with a seroma with drainage from the graft at the antecubital fossa side and was admitted to the hospital. The health care provider (hcp) repaired the arteriovenous graft and performed excision of the seroma. The patient reportedly tolerated the procedure well and was discharged the following day. The event was considered resolved on the date of hospital discharge. New information: received and reviewed medical records. Nine days post surgical implant of an av graft the patient presented with drainage from a seroma (fluid collection under the skin) located at the site of the surgical incision. The patient was admitted to the hospital and given 5000 units of heparin, subcutaneously, every eight hours. The following day the seroma was opened, irrigated with heparin solution and closed. The patient was discharged from the hospital following the drainage procedure. New information: it was reported that approximately sixty two days after the patient had been implanted with a surgical graft, the patient experienced an alleged (unspecified) infection requiring hospitalization. No other information has been provided at this time, this file will be updated further if more information is provided. New information: the seroma was treated with antibiotics at the right upper extremity graft incision access site, and drained. The issue was considered resolved; however, the following day the patient experience an unspecified infection which was treated with antibiotic therapy, incision, and drainage of the right arm access site and placed a vacuum assisted closure (vac). The event was considered resolved on the date of hospital discharge. Ninety six days after implantation of the graft, the patient again experiences an unspecified alleged infection and was hospitalized for revision and excision of the a/v graft. No other information has been provided at this time, this file will be updated further if more information is provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-00963 |
| MDR Report Key | 6029060 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-13 |
| Date of Report | 2016-09-19 |
| Date of Event | 2016-08-31 |
| Date Mfgr Received | 2017-01-19 |
| Date Added to Maude | 2016-10-13 |
| 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 GRAFTS |
| Generic Name | EPTFE VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2016-10-13 |
| Catalog Number | 40S06 |
| 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. Required No Informationntervention | 2016-10-13 |