FDA Adverse Event
Death
Summary report: N
GORE-TEX VASCULAR GRAFT
MDR report key: 1731056
·
Received June 17, 2010
Report
- Report Number
- 2017233-2010-00293
- Event Type
- Death
- Date Received
- June 17, 2010
- Report Date
- June 16, 2010
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- PMA / PMN Number
- K802095
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON AN UNK DATE, A (B)(6) FEMALE PATIENT WAS IMPLANTED WITH A GORE-TEX VASCULAR GRAFT IN AN AV ACCESS APPLICATION IN THE RIGHT ARM. IT WAS REPORTED TO GORE THAT THE PATIENT LOST 300 ML OF BLOOD. THE PATIENT THEREAFTER UNDERWENT EMERGENCY MEDICAL TREATMENT. ON (B)(6) 2009, THE PATIENT EXPIRED. FURTHER INVESTIGATION IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE-TEX VASCULAR GRAFT | DSY/PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | DSY | W.L. GORE & ASSOCIATES | WLG250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death |