FDA Adverse Event
Injury
Summary report: N
GORE DRYSEAL SHEATH
MDR report key: 2894001
·
Received December 18, 2012
Report
- Report Number
- 2017233-2012-00845
- Event Type
- Injury
- Date Received
- December 18, 2012
- Date of Event
- November 20, 2012
- Report Date
- November 20, 2012
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DYB
- PMA / PMN Number
- K093791
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE ROOT CAUSE OF THE ILIAC ARTERY RUPTURE IS UNK.
Description of Event or Problem · 1
ON (B)(6) 2012, THIS PT UNDERWENT AN ENDOVASCULAR PROCEDURE WITH A GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, AFTER THE ANEURYSM WAS EXCLUDED, THE PHYSICIAN BEGAN TO WITHDRAW THE GORE DRYSEAL SHEATH (SDV2028/9996996) FROM THE RIGHT ILIAC ARTERY. AT THAT TIME THE ILIAC ARTERY RUPTURED AND BLOOD LOSS WAS EXCESS OF A LITER. A DACRON GRAFT WAS USED TO REPAIR THE ILIAC ARTERY. THE PT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE DRYSEAL SHEATH | DYB/INTRODUCER, CATHETER | DYB | W.L. GORE & ASSOCIATES | 9996996 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |