FDA Adverse Event
Other
Summary report: N
VECTRA VASCULAR ACCESS GRAFT
MDR report key: 399688
·
Received June 13, 2002
Report
- Report Number
- 2916596-2002-00021
- Event Type
- Other
- Date Received
- June 13, 2002
- Date of Event
- February 17, 2002
- Report Date
- June 12, 2002
- Manufacturer
- THORATEC CORP.
- Product Code
- DSY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A VECTRA GRAFT WAS IMPLANTED IN A FOREARM LOOP CONFIGURATION FOR AV ACCESS IN A PATIENT. THREE WEEKS LATER IT WAS DISCOVERED THAT PART OF THE GRAFT (AT THE LOOPED APEX IN THE WRIST) HAD ERODED THROUGH THE SKIN. IN 2002, A SKIN FLAP PROCEDURE WAS PERFORMED TO COVER A PART OF THE GRAFT THAT HAD ERODED THROUGH THE SKIN. SIX DAYS LATER, ANOTHER SKIN FLAP PROCEDURE WAS PERFORMED. NO GRAFT REMOVAL WAS NECESSARY, THE GRAFT REMAINS IMPLANTED AND IS FUNCTIONING WELL.
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 | 8506-3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |