FDA Adverse Event
Death
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 2023880
·
Received March 14, 2011
Report
- Report Number
- 2017233-2011-00131
- Event Type
- Death
- Date Received
- March 14, 2011
- Date of Event
- February 2, 2011
- Report Date
- March 14, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. ACCORDING TO THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE GORE TAG THORACIC ENDOPROSTHESIS HAS NOT BEEN EVALUATED IN PTS WITH ACUTE AND CHRONIC DISSECTIONS.
Description of Event or Problem · 1
ON (B)(6) 2011, THE PT PRESENTED WITH A RUPTURED ACUTE AORTIC DISSECTION. THE PT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS AND A TALENT STENT GRAFT. THE TALENT GRAFT INTENTIONALLY COVERED THE LEFT SUBCLAVIAN ARTERY. COIL EMBOLIZATION WAS STARTED FOR THE LEFT SUBCLAVIAN ARTERY; HOWEVER, EXTENSION OF THE DISSECTION AND A NEW RUPTURE OCCURRED. ON (B)(6) 2011, THE PT EXPIRED.
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 | WLG426 | 8344031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Death |