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 2017-02-27 for IMPRA VASCULAR GRAFT 40S06 manufactured by Bard Peripheral Vascular, Inc..
[68402256]
No device, no medical records and 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 investigation of the reported event is currently underway. Clinical trial review: the patient with end stage renal disease had an expanded. Polytetrafluoroethylene vascular access conduit surgically inserted in the left upper arm for hemodialysis. Two-hundred thirty-three (233) days post placement, the patient was hospitalized for an infection of the vascular access described as a large hole and bleeding at the site. The patient was placed on antibiotic therapy and two days later, the conduit was excised and ligated. A temporary dialysis catheter was placed during the hospitalization. An anerobic culture of the left upper arm was negative for growth on the final report. 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
[68402257]
It was reported through the results of a clinical trial, that 233 days post placement of a left upper arm expanded polytetrafluoroethylene vascular access conduit, the patient was hospitalized for an infection of the vascular access. The patient was placed on antibiotic therapy. Two days later, the conduit was removed and a temporary dialysis catheter was placed. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[71849761]
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed. The lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported for this lot number and issue to date. 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. Clinical trial review: the patient with end stage renal disease had an expanded polytetrafluoroethylene arteriovenous (av) vascular access graft surgically inserted in the left upper arm for hemodialysis. Approx 233 days post placement, the patient presented to the emergency room vomiting with fever and was found to have evidence of early sepsis. Initially, the source of infection was believed to be gastrointestinal as a ct scan demonstrated evidence of distal colitis. The patient was admitted and intravenous (iv) hydration and antibiotic therapy was initiated. The av graft was noted to be functioning; however, infection was suspected due to site discoloration and lack of thrill. A nephrology consult was obtained recommending continued hemodialysis and antibiotics for the definite av graft infection described as a large hole and bleeding at the site. A consult with infectious disease for blood cultures which were positive for (b)(6) recommended vancomycin and zosyn therapy for the presence of colitis as well as recent recurrent pseudomonas urinary tract infection. Approx 235 days post placement, excision and ligation of the left upper extremity av graft with washout and wound packing, and insertion of a double lumen right internal jugular venous dialysis catheter were performed. Eight days post av graft excision, the patient was afebrile with an improved white blood cell (wbc); therefore, a permanent tunneled hemodialysis catheter was placed. The next day, with the event resolved, the patient was discharged home. Home health care was ordered for completion of iv antibiotic course and twice daily wet-to-dry dressing changes of the left upper extremity. The patient was to follow-up as instructed. Image/photo review: no images or photos have been made available to the manufacturer. Conclusion: the device was not returned. Images were not provided. Medical records were not provided. Clinical trial information was provided and reviewed. Approx 233 days post placement, the patient presented to the emergency room vomiting with fever and was found to have evidence of early sepsis. The av graft was noted to be functioning; however, infection was suspected due to site discoloration and lack of thrill. Approx 235 days post placement, excision and ligation of the left upper extremity av graft with washout and wound packing, and insertion of a double lumen right internal jugular venous dialysis catheter were performed. The investigation is inconclusive for causing the infection. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: warnings: 1. All impra? Eptfe vascular grafts are supplied sterile and nonpyrogenic unless the package is open or damaged. Impra? Eptfe vascular grafts are sterilized by ethylene oxide. Each graft is intended for single patient use only. Do not resterilize. Adverse reactions: potential complications which may occur with any surgical procedure involving a vascular prosthesis include, but are not limited to: swelling of the implanted limb; and/or infection. (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
[71849762]
It was reported through the results of a clinical trial, that 233 days post placement of a left upper arm expanded polytetrafluoroethylene vascular access conduit, the patient was hospitalized for an infection of the vascular access. The patient was placed on antibiotic therapy. Two days later, the conduit was removed and a temporary dialysis catheter was placed. No additional information was provided. Additional information received: the patient presented to the emergency room with vomiting, fever, and access site discoloration with lack of thrill noted. The patient was admitted and intravenous (iv) hydration and antibiotics for blood cultures positive for (b)(6) were initiated. Two days later, excision and ligation of the left upper extremity av graft with washout and wound packing, and insertion of a right internal jugular venous dialysis catheter was performed. Eight days post graft excision, a permanent tunneled hemodialysis catheter was placed. The patient was discharged on post surgical day nine for home health to continue iv antibiotic course and wet-to-dry dressing changes of the left upper extremity. The patient was to follow-up as instructed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2017-00109 |
| MDR Report Key | 6360613 |
| Report Source | HEALTH PROFESSIONAL,STUDY,USE |
| Date Received | 2017-02-27 |
| Date of Report | 2017-03-27 |
| Date of Event | 2017-01-24 |
| Date Mfgr Received | 2017-02-28 |
| Device Manufacturer Date | 2015-11-30 |
| Date Added to Maude | 2017-02-27 |
| 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 | VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2017-02-27 |
| Catalog Number | 40S06 |
| Lot Number | VTZK0787 |
| 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 | 2017-02-27 |