FDA Adverse Event
Death
Summary report: N
GORE® TAG® THORACIC ENDOPROSTHESIS
MDR report key: 5640665
·
Received May 9, 2016
Report
- Report Number
- 2017233-2016-00456
- Event Type
- Death
- Date Received
- May 9, 2016
- Date of Event
- June 12, 2010
- Report Date
- April 11, 2016
- 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
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING A GORETAGTHORACIC ENDOPROSTHESES (TGT3115/7165019, TGT3420/7160425) FOR A THORACIC AORTIC ANEURYSM RUPTURE AND ESOPHAGEAL FISTULA REPAIR. THE ANEURYSM DIAMETER WAS 60 MM. ON (B)(6) 2010, THE PATIENT UNDERWENT AN ESOPHAGECTOMY PROCEDURE. ON (B)(6) 2010, DEVICE-RELATED INFECTION WAS REPORTED. ON (B)(6) 2010, THE PATIENT PASSED AWAY DUE TO AN ANEURYSM RUPTURE. THE PHYSICIAN COMMENTED THAT THE INFECTION CAUSED ANEURYSM ENLARGEMENT AND WEAKENING OF THE PROXIMAL NECK SEALING, WHICH MAY HAVE LED TO THE ANEURYSM RUPTURE. NO FURTHER INFORMATION WAS OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297128 | GORE® TAG® THORACIC ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 7165019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Death | (B)(6) 2010: TGT3420/7160425 |