FDA Adverse Event
Death
Summary report: N
GORE® TAG® THORACIC ENDOPROSTHESIS
MDR report key: 5146311
·
Received October 13, 2015
Report
- Report Number
- 2017233-2015-00700
- Event Type
- Death
- Date Received
- October 13, 2015
- Date of Event
- September 23, 2015
- Report Date
- September 14, 2015
- 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
THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A RUPTURE OF A THORACO-ABDOMINAL AORTIC ANEURYSM USING TWO GORE TAG THORACIC ENDOPROSTHESES (TGT3420/8124343, TGT3415/8032683). THE PATIENT UNDERWENT VASCULAR RECONSTRUCTION FOR CELIAC TRUNK, SUPERIOR MESENTERIC ARTERY AND BOTH RENAL ARTERIES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, THE PATIENT UNDERWENT SURGERY TO REMOVE A BLOOD CLOT ON LEFT LOWER LIMB DUE TO THROMBOTIC DISEASE. THE PATIENT PASSED AWAY DUE TO MULTIPLE ORGAN FAILURE ON THE SAME DAY. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 677179 | GORE® TAG® THORACIC ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 8124343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Death |