FDA Adverse Event
Injury
Summary report: N
GORE HYBRID VASCULAR GRAFT
MDR report key: 2250013
·
Received September 9, 2011
Report
- Report Number
- 2017233-2011-00460
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- August 17, 2011
- Report Date
- September 8, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2011, AN 8MM GORE HYBRID VASCULAR GRAFT WAS IMPLANTED IN A PATIENT'S LEFT UPPER ARM, FROM THE BRACHIAL ARTERY TO THE AXILLARY VEIN. REPORTEDLY, THE PHYSICIAN EXPRESSED CONCERN ABOUT THE SIZE OF THE PATIENT'S ARTERY (APPROX 4MM). ON (B)(6) 2011, THE HYBRID GRAFT WAS LIGATED DUE TO AN ARTERIAL STEAL SYNDROME. THE GRAFT WAS ABANDONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE HYBRID VASCULAR GRAFT | NONE | DSY | W.L. GORE & ASSOCIATES | WLG417 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |