FDA Adverse Event
Injury
Summary report: N
SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM
MDR report key: 2967485
·
Received February 13, 2013
Report
- Report Number
- 3005325609-2013-00003
- Event Type
- Injury
- Date Received
- February 13, 2013
- Date of Event
- January 15, 2013
- Report Date
- January 18, 2013
- Manufacturer
- IDEV TECHNOLOGIES, INC.
- Product Code
- FGE
- PMA / PMN Number
- K093893
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS IMPLANTED AND WILL NOT BE RETURNED. THE COMPANY REPRESENTATIVE IS ATTEMPTING TO GATHER THE PRODUCT AND PT'S WEIGHT. A SUPPLEMENTAL MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
THE PT EXPERIENCED IN-STENT RESTENOSIS. IMAGES SHOWED A DEFORMATION IN THE STENT IN THE AREA OF RESTENOSIS. THE STENT WAS ORIGINALLY IMPLANTED 12-18 MONTHS PRIOR TO THE EVENT. THE PT WAS TREATED WITH PTA AND A STENT PLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64067 | SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM | FGE | IDEV TECHNOLOGIES, INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization |