FDA Adverse Event
Injury
Summary report: N
CARBOFLO VASCULAR GRAFT
MDR report key: 1982265
·
Received February 1, 2011
Report
- Report Number
- 2020394-2011-00015
- Event Type
- Injury
- Date Received
- February 1, 2011
- Date of Event
- December 8, 2010
- Report Date
- January 6, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DYF
- PMA / PMN Number
- K004012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED AND A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THIRTY DAYS AFTER AN EXTRA-ANATOMICAL IMPLANT OF A THIN WALL EPTFE VASCULAR GRAFT IN THE AXILLO-FEMORAL POSITION, A PSEUDOANEURYSM WAS OBSERVED AT THE DISTAL ANASTOMOSIS. SURGICAL REVISION WAS ATTEMPTED, HOWEVER, THE GRAFT TORE WHILE BEING SUTURED. THE TORN SECTION OF GRAFT WAS REPLACED WITH ANOTHER GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARBOFLO VASCULAR GRAFT | DYF | BARD PERIPHERAL VASCULAR, INC. | VTTL0373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |