FDA Adverse Event
Other
Summary report: N
VECTRA VASCULAR ACCESS GRAFT
MDR report key: 415196
·
Received September 6, 2002
Report
- Report Number
- 2916596-2002-00037
- Event Type
- Other
- Date Received
- September 6, 2002
- Date of Event
- March 7, 2002
- Report Date
- September 6, 2002
- Manufacturer
- THORATEC CORP.
- Product Code
- DSY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT DEVELOPED A STAPH. AUREUS INFECTION IN A VECTRA GRAFT PLACED IN A LOOP CONFIGURATION IN THE LEG. WHEN REMOVING THE INFECTED GRAFT, THE PHYSICIAN REPORTED THAT THE OUTER POROUS LAYER WAS NOT VISIBLE ON THE ENTIRE LENGTH OF THE GRAFT AND THE SUPPORT FIBERS WERE SURROUNDING THE SOLID MIDDLE LAYER OF THE GRAFT. BOTH SUTURE LINES WERE INTACT, AS THE SUTURES WERE SECURED IN THE SOLID MIDDLE LAYER OF THE GRAFT. THE PT WAS TREATED SUCCESSFULLY WITH ANTIBIOTICS AND WAS DIALYZED WITH A CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VECTRA VASCULAR ACCESS GRAFT | VASCULAR ACCESS GRAFT | DSY | THORATEC CORP. | 10002-6040-001 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |