FDA Adverse Event
Injury
Summary report: N
GORE® TAG® THORACIC ENDOPROSTHESIS
MDR report key: 5357180
·
Received January 11, 2016
Report
- Report Number
- 2017233-2016-00037
- Event Type
- Injury
- Date Received
- January 11, 2016
- Date of Event
- December 14, 2010
- Report Date
- December 21, 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
(B)(4). THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. THE CAUSE OF THE ANEURYSM GROWTH IS UNKNOWN. THE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE STATE THAT POTENTIAL DEVICE OR PROCEDURE RELATED ADVERSE EVENTS INCLUDE ANEURYSM ENLARGEMENT.
Description of Event or Problem · 1
ON (B)(6) 2008, THE PATIENT UNDERWENT A PROCEDURE USING GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A THORACIC ANEURYSM. IT WAS REPORTED ON DISCHARGE DATE OF (B)(6) 2008, THE ANEURYSM MEASURED 31 MM. FOLLOW UP DATES AND ANEURYSM MEASUREMENT: (B)(6) 2009: 31.0 MM, (B)(6), 2009: UNK, (B)(6) 2010: 48 MM, (B)(6), 2012: UNK. IT IS UNKNOWN WHY THE ANEURYSM SAC HAS ENLARGED AND THERE HAS BEEN NO REPORTED REINTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 16097 | GORE® TAG® THORACIC ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 06409299 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other |