FDA Adverse Event
Injury
Summary report: N
GORE-TEX SUTURE
MDR report key: 1241724
·
Received November 20, 2008
Report
- Report Number
- 3003910212-2008-00048
- Event Type
- Injury
- Date Received
- November 20, 2008
- Date of Event
- October 22, 2008
- Report Date
- November 20, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- GAW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 1
IT WAS REPORTED TO GORE THE FOLLOWING: A VERY HEAVY AND TALL PATIENT WITH A LARGE HEART UNDERWENT MITRAL VALVE REPAIR WITH GORE-TEX SUTURE USED FOR ARTIFICIAL CHORDAE. THE DATE OF INITIAL OPERATION IS UNKNOWN AT THIS TIME. HE (THE PATIENT) RETURNED WITH MITRAL REGURGITATION. ON RE-INTERVENTION, THE SURGEON FOUND MULTIPLE ARTIFICIAL CHORDAES WERE RUPTURED. THE RE-OPERATION WAS UNEVENTFUL AND THE PATIENT WAS RELEASED FROM HOSPITAL AFTER THE REGULAR STAY, AND IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE-TEX SUTURE | NONE | GAW | W.L. GORE & ASSOCIATES | WLG601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |