FDA Adverse Event
Other
Summary report: N
BRIDGE ASSURANT BILIARY STENT SYSTEM
MDR report key: 568834
·
Received January 28, 2005
Report
- Report Number
- 2953200-2005-01019
- Event Type
- Other
- Date Received
- January 28, 2005
- Date of Event
- January 1, 2004
- Report Date
- December 30, 2004
- Manufacturer
- MEDTRONIC VASCULAR
- Product Code
- FGE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AN 8 MM DIAMETER X 4.0 CM LENGTH BRIDGE ASSURANT BILIARY STENT WAS IMPLANTED INTO A PT FOR THE TREATMENT OF AN UNKNOWN LESION. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT AFTER THE STENT WAS DEPLOYED, THE BALLOON WAS DIFFICULT TO DEFLATE. SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, THE USER FACILITY DID NOT PROVIDE ADDITIONAL INFORMATION. MEDTRONIC RECEIVED THE STENT DELIVERY SYSTEM IN 2005 AND ITS INVESTIGATION IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRIDGE ASSURANT BILIARY STENT SYSTEM | PERIPHERAL STENT SYSTEM | FGE | MEDTRONIC VASCULAR | NA | 3A16E03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |