FDA Adverse Event
Other
Summary report: N
GELSOFT PLUS THIN WALL
MDR report key: 2737443
·
Received December 18, 2006
Report
- Report Number
- 9612515-2006-00003
- Event Type
- Other
- Date Received
- December 18, 2006
- Date of Event
- November 18, 2006
- Report Date
- December 15, 2006
- Manufacturer
- VASCUTEK LTD.
- Product Code
- DSY
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ONLY YEAR OF IMPLANT, 2002 IS KNOWN. METHOD: EXAMINATION OF SECTION OF GRAFT TO BE CARRIED OUT.
Description of Event or Problem · 1
IN 2002 IN SAPPORO-SHI (B)(6) A PT WAS IMPLANTED WITH A GELSOFT PLUS THIN WALL GRAFT FOR A FEM-FEM BYPASS OPERATION. ON (B)(6) 2006, DOCTOR SUSPECTED A PSEUDOANEURYSM. DOCTOR EXPLANTED GRAFT FROM PT AND FOUND THERE WAS A PINHOLE IN THE GRAFT NEAR THE ANASTOMOSIS. THE PT WAS IMPLANTED WITH ANOTHER GELSOFT PLUS THIN WALL GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GELSOFT PLUS THIN WALL | VASCULAR PROSTHESIS | DSY | VASCUTEK LTD. | 616008TN | 41321 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |