FDA Adverse Event
Injury
Summary report: N
GORE VIATORR® TIPS ENDOPROSTHESIS
MDR report key: 3962005
·
Received July 28, 2014
Report
- Report Number
- 3007284313-2014-00064
- Event Type
- Injury
- Date Received
- July 28, 2014
- Date of Event
- July 11, 2014
- Report Date
- July 29, 2014
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIR
- PMA / PMN Number
- P040027
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND THE DELIVERY SYSTEM WAS DISCARDED, SO NO ENGINEERING INVESTIGATION COULD BE PERFORMED.
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT ON (B)(6) 2014 THE PHYSICIAN IMPLANTED A GORE® VIATORR® TIPS ENDOPROSTHESIS. DUE TO EXCESSIVE THROMBOSIS, THROMBOLYSIS WAS PERFORMED ON THE DEVICE. ON (B)(6) 2014 A RE-INTERVENTION WAS PERFORMED TO RELINE THE DEVICE THAT WAS ALREADY IN PLACE. ANOTHER VIATORR DEVICE WAS ADVANCED AND DEPLOYED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 438214 | GORE VIATORR® TIPS ENDOPROSTHESIS | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS | MIR | W.L. GORE & ASSOCIATES | 12379259 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other |