MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-14 for GORE PROPATEN VASCULAR GRAFT HT087080 manufactured by W.l. Gore & Associates.
[174902975]
On (b)(6) 2019, a patient underwent an axillary to bifemoral artery bypass procedure. On (b)(6) 2019 a reintervention took place using a gore propaten vascular graft. During the reintervention there was bleeding noted midgraft after tunnelling with an atrium tunneller. This required the use of pledgets for patching. Mild traction was placed on the graft during the procedure and this resulted in the graft fracturing and separating from the axillary end. A 6 mm atrium tunneller was passed through the graft but it perforated the graft at the groin end. The entire graft was explanted. The status of the patient is unknown currently.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00031 |
| MDR Report Key | 9587017 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-14 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-12-05 |
| Device Manufacturer Date | 2019-07-14 |
| Date Added to Maude | 2020-01-14 |
| 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 | HEIDI INSKEEP |
| 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 PROPATEN VASCULAR GRAFT |
| Generic Name | PROSTHESIS, VASCULAR GRAFT |
| Product Code | DSY |
| Date Received | 2020-01-14 |
| Returned To Mfg | 2020-01-21 |
| Catalog Number | HT087080 |
| Lot Number | 6431947PP008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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; 2. Other; 3. Required No Informationntervention | 2020-01-14 |