FDA Adverse Event
Death
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 835554
·
Received April 5, 2007
Report
- Report Number
- 2017233-2007-00101
- Event Type
- Death
- Date Received
- April 5, 2007
- Date of Event
- March 15, 2007
- Report Date
- April 5, 2007
- Manufacturer
- W.L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
IN 2007 THE PATIENT WAS TREATED WITH THE GORE TAG THORACIC ENDOPROSTHESIS. THE DEVICES WERE SUCCESSFULLY DEPLOYED. AS THE SHEATH WAS BEING EXTRACTED FROM THE RIGHT COMMON ILIAC, IT TORE THE VESSEL. THE PATIENT'S BLOOD PRESSURE DROPPED AND CONTROL OF THE TORN VESSEL COULD NOT BE OBTAINED. THE PATIENT WENT INTO CARDIAC ARREST AND DIED. THE OFFICIAL CAUSE OF DEATH WAS STATED AS CARDIAC ARREST SECONDARY TO ACUTE BLOOD LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE TAG THORACIC ENDOPROSTHESIS | ENDOVASCULAR GRAFT SYSTEM | MIH | W.L. GORE & ASSOCIATES, INC. | TS2430 | 0451153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 96 YR | Death |