FDA Adverse Event
Injury
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 2328793
·
Received November 4, 2011
Report
- Report Number
- 2017233-2011-00581
- Event Type
- Injury
- Date Received
- November 4, 2011
- Date of Event
- October 27, 2011
- Report Date
- November 3, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADD'L DEVICES: 904712/TGT3415, 8945554/TGT3420.
Description of Event or Problem · 1
ON (B)(6) 2011, THE PT PRESENTED WITH A RUPTURED ACUTE THORACIC DISSECTION. THE PT WAS IMPLANTED WITH THREE GORE TAG THORACIC ENDOPROSTHESES. THE PT TOLERATED THE PROCEDURE. ON (B)(6) 2011, THE PT PRESENTED WITH WEAKNESS OF THE LEFT SIDE. THE CAUSE WAS THOUGHT TO BE SPINAL CHORD ISCHEMIA. A SPINAL DRAIN WAS PLACED. ON (B)(6) 2011, THE SPINAL DRAIN WAS REMOVED. THE PT HAS RESIDUAL WEAKNESS ON THE LEFT SIDE, BUT IS STILL IMPROVING.
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 | 7517795 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| O| R | ASPIRIN| METOPROLOL| ALBUTEROL| LISINOPRIL| TYLENOL |