FDA Adverse Event
Injury
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 3170418
·
Received June 7, 2013
Report
- Report Number
- 2017233-2013-00363
- Event Type
- Injury
- Date Received
- June 7, 2013
- Date of Event
- August 4, 2009
- Report Date
- May 9, 2013
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6) 2009, THIS PT UNDERWENT ENDOVASCULAR TREATMENT TO REPAIR A THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESIS. POST TOUCH UP BALLOONING A RETROGRADE DISSECTION WAS FOUND PROXIMAL TO THE DEVICE. AN ADDITIONAL GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED PROXIMALLY TO REPAIR THE DISSECTION ENTRY POINT. ON (B)(6) 2009, THE DISSECTION HAD RESOLVED AND THE PT WAS DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253399 | GORE TAG THORACIC ENDOPROSTHESIS | MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 06690568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Hospitalization |