FDA Adverse Event
Death
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 1676959
·
Received May 5, 2010
Report
- Report Number
- 2017233-2010-00208
- Event Type
- Death
- Date Received
- May 5, 2010
- Date of Event
- April 24, 2010
- Report Date
- May 5, 2010
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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. ADDITIONAL DEVICE USED IN PROCEDURE: TG4020/7002235.
Description of Event or Problem · 1
ON (B) (6) 2010, THIS PT UNDERWENT EMERGENT REPAIR OF A PREVIOUSLY UNDIAGNOSED TYPE B DISSECTING AND RUPTURED THORACIC AORTA USING GORE TAG THORACIC ENDOPROSTHESES. THE PLACEMENT OF THE DEVICES OCCURRED WITHOUT INCIDENT. THE PHYSICIAN BELIEVES THAT THE DISSECTION MAY HAVE PROGRESSED PROXIMALLY AFTER IMPLANT OF THE DEVICES. THE PT'S BLOOD PRESSURE COULD NOT BE STABILIZED DURING THE PROCEDURE, SUBSEQUENTLY THE PT EXPIRED SEVERAL HOURS POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE TAG THORACIC ENDOPROSTHESIS | MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | WLG326 | 7674272 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Death | LOVENOX |