FDA Adverse Event
Injury
Summary report: N
GORE-TEX INTERING STRETCH VASCULAR GRAFT
MDR report key: 850808
·
Received May 11, 2007
Report
- Report Number
- 2017233-2007-00126
- Event Type
- Injury
- Date Received
- May 11, 2007
- Report Date
- May 10, 2007
- Manufacturer
- W.L. GORE & ASSOCIATES, INC
- Product Code
- DSY
- PMA / PMN Number
- k991602
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LOT NUMBER IS UNK; THEREFORE, A REVIEW OF THE MFG RECORDS COULD NOT BE PERFORMED AT THIS TIME.
Description of Event or Problem · 1
APPROX 23 WKS POSTOP, THE PT PRESENTED WITH FOUR PSEUDOANEURYSMS AFTER A FEW DIALYSIS SESSIONS WITH THE GORE-TEX INTERING STRETCH VASCULAR GRAFT. THE SURGEON RECONSTRUCTED THE AREAS OF THE GRAFT EXHIBITING THE PSEUDOANEURYSMS WITH ANOTHER PART OF AN INTERING GRAFT. THE PHYSICIAN IS UNCERTAIN TO DATE (04/13/2007), BUT DOES NOT BELIEVE THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE WILL BE RETURNED FOR EXAMINATION. TO DATE (04/13/2007), THE PT'S STATUS IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE-TEX INTERING STRETCH VASCULAR GRAFT | DSY | DSY | W.L. GORE & ASSOCIATES, INC | WLG411 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |