MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-18 for GORE-TEX? VASCULAR GRAFT manufactured by W.l. Gore & Associates.
[186738033]
(b)(6) 2018 was taken as the date of event, because the infection was diagnosed on this date. On (b)(6) 2018 was taken as the best estimate of the date of implant. The phone number of the physician could not be obtained. The investigation involved e-mail communication with the healthcare professional performing the explant evaluation. The explanted device was not returned to gore for evaluation. At present the device is located at an independed laboratory (b)(6). The independed laboratory geprovas provided gore with a preliminary explant evaluation. No analysis of relevant production records in view of supporting the identification of possible causes for the adverse event could be performed, because the lot number of the device remains unknown.
Patient Sequence No: 1, Text Type: N, H10
[186738034]
A gore-tex? Vascular graft was implanted in a (b)(6) female patient in (b)(6) 2018 as a femoro-femoral bypass in order to treat a critical ischemia. Reportedly the patient did not have a history of pre-existing infection in the field of treatment. It was reported, that, on (b)(6) 2018, an infection was identified. It was stated, that on (b)(6) 2018, imaging was performed presenting an anastomotic pseudoaneurysm and a possible breach near the anastomosis. Reportedly, on (b)(6) 2018, the gore-tex? Vascular graft was explanted due to the infection and the pseudoaneurysm. It was reported, that the surgeon performed a prostheto-prosthetic bypass to repair the issue locally. It was stated, that the patient received antipyretic and antibiotic treatment. It was reported, that the patient is doing well. In the provided explant report it is stated, that the gore-tex? Vascular graft was separated in two segments. One of this explanted segments revealed a total obstruction of the prosthetic lumen due to the loss of some reinforcement rings allowing the graft to collapse. Moreover, a green multifilament has been used as a ligature. The physician stated, that the infection was neither caused by the gore-tex? Vascular graft nor did the gore-tex? Vascular graft contribute to the infection. The physician also stated, that the infection was neither caused by the procedure to implant the gore-tex? Vascular graft nor did the procedure contribute to the infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00046 |
| MDR Report Key | 9604734 |
| Date Received | 2020-01-18 |
| Date of Report | 2020-03-03 |
| Date of Event | 2018-10-04 |
| Date Added to Maude | 2020-01-18 |
| 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 | SIBYLLE STAERK |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL WEST B/P |
| Manufacturer Street | 1505 N. FOURTH STREET |
| Manufacturer City | FLAGSTAFF AZ 86004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE-TEX? VASCULAR GRAFT |
| Generic Name | PROSTHESIS, VASCULAR GRAFT |
| Product Code | DSY |
| Date Received | 2020-01-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-18 |