FDA Adverse Event
Malfunction
Summary report: N
GORE VIATORR TIPS ENDOPROSTHESIS
MDR report key: 2221405
·
Received August 16, 2011
Report
- Report Number
- 2017233-2011-00423
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 12, 2011
- Report Date
- August 15, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIR
- PMA / PMN Number
- P040027
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE CHAIN-LINK SEGMENT WAS DEPLOYED INTO THE PORTAL VEIN. AS THE PHYSICIAN PULLED THE DEPLOYMENT KNOB, THE DEPLOYMENT LINE STUCK AND FAILED TO INITIATE DEPLOYMENT. THE CHAIN-LINK SEGMENT COULD NOT BE DUPLICATED; THEREFORE, THE PHYSICIAN WITHDREW THE DEVICE THROUGH A COOK SHEATH AND REMOVED FROM THE PT. THERE WERE NO PT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE VIATORR TIPS ENDOPROSTHESIS | MIR / SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS | MIR | W.L. GORE & ASSOCIATES | WLG315 | 8436763 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |