FDA Adverse Event
Malfunction
Summary report: N
BRIDGE ASSURANT BILIARY STENT SYSTEM
MDR report key: 615700
·
Received May 5, 2005
Report
- Report Number
- 2953200-2005-01125
- Event Type
- Malfunction
- Date Received
- May 5, 2005
- Date of Event
- April 29, 2005
- Report Date
- May 5, 2005
- Manufacturer
- MEDTRONIC VASCULAR
- Product Code
- FGE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AN 8MM X 30MM BRIDGE ASSURANT STENT WAS IMPLANTED INTO A PATIENT FOR THE TREATMENT OF A STENOSED RENAL ARTERY LESION. IT IS UNKNOW IF THE LESION WAS PRE-DILATED. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT DURING THE DEPLOYMENT OF THE STENT GRAFT THE BALLOON BURST AT UNKNOWN ATMOSPHERE. THE ENTIRE STENT DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE STENT DELIVERY SYSTEM WAS RECEIVED FOR ANSLYSIS, HOWEVER, THE COMPLETED ANALYSIS IS PENDING. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS REPORTED TO BE FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRIDGE ASSURANT BILIARY STENT SYSTEM | PERIPHERAL STENT SYSTEM | FGE | MEDTRONIC VASCULAR | NA | 487228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |