FDA Adverse Event
Injury
Summary report: N
GORE-TEX CARDIOVASCULAR PATCH
MDR report key: 3021054
·
Received March 12, 2013
Report
- Report Number
- 3007284313-2013-00010
- Event Type
- Injury
- Date Received
- March 12, 2013
- Date of Event
- January 17, 2013
- Report Date
- February 26, 2013
- Manufacturer
- W. L. GORE ASSOCIATES
- Product Code
- DXZ
- PMA / PMN Number
- K811841
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED A PATIENT UNDERWENT FEMORAL ARTERY PATCH ANGIOPLASTY. A GORE-TEX CARDIOVASCULAR PATCH WAS USED. FOLLOWING THE PROCEDURE, IN THE POST ANESTHESIA RECOVERY UNIT, THE PATIENT BEGAN BLEEDING. THE PATIENT WAS TAKEN BACK TO SURGERY. THE UPPER HALF OF THE PATCH WAS FOUND TO BE DETACHED FROM ITS PLACEMENT SITE AND BLEEDING. THE SURGEON RE-SUTURED THE SAME PATCH IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104456 | GORE-TEX CARDIOVASCULAR PATCH | DXZ / PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE | DXZ | W. L. GORE ASSOCIATES | 9546411 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |