FDA Adverse Event
Death
Summary report: N
GORE
MDR report key: 653615
·
Received August 25, 2005
Report
- Report Number
- MW1036431
- Event Type
- Death
- Date Received
- August 25, 2005
- Date of Event
- August 8, 2005
- Report Date
- August 23, 2005
- Manufacturer
- GORE
- Product Code
- DSY
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ENDOLUMINAL STENTING. ANGIO AND CT EVIDENCE OF L CAROTID BEING UNOBSTRUCTED; PT ALSO NEURO O.K. THREE DAYS LATER L CVA (SMALL) FOLLOWED 1 WEEK LATER BY LARGE L CVA. POST-MORTEM REVEALED SLIPPAGE OF GRAFT WITH SLIPPAGE OF SHEATH BOTH PROX DO L CAROTID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE | TAG | DSY | GORE | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Death |