MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-27 for GORE PROPATEN VASCULAR GRAFT H080040A manufactured by W.l. Gore & Associates.
[181184553]
Additional manufacturer narrative: a review of the manufacturing records indicated the device met pre-release specifications. The device was not returned for an engineering evaluation. Consequently, a direct product analysis was not possible. Additional information about this event could not be obtained. As a result, no further investigation is possible. 2 devices were reported to gore. Reference medwatch 2017233-2020-00082 for second device.
Patient Sequence No: 1, Text Type: N, H10
[181184674]
The following was reported to gore: on (b)(6) 2019 an 8mm gore? Propaten? Vascular graft was implanted as a bypass, common iliac to distal sfa. On (b)(6) 2020 the physician performed a re-exploration as a result of an identified occlusion within the graft. The doctor performed a graft thrombectomy as well as revision of the distal anastomosis, extending treatment by sewing a second graft to the distal anastomosis to the popliteal below knee position. On (b)(6) the graft to graft anastomosis disrupted. According to the doctor, the patient bled out very rapidly and expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00132 |
| MDR Report Key | 9764624 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-27 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-15 |
| Device Manufacturer Date | 2019-03-12 |
| Date Added to Maude | 2020-02-27 |
| 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 | NICK LA FAVE |
| 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 PROPATEN VASCULAR GRAFT |
| Generic Name | PROSTHESIS, VASCULAR GRAFT |
| Product Code | DSY |
| Date Received | 2020-02-27 |
| Model Number | H080040A |
| Catalog Number | H080040A |
| Lot Number | 6299684PP033 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Death | 2020-02-27 |