FDA Adverse Event
Injury
Summary report: N
EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
MDR report key: 615472
·
Received June 17, 2005
Report
- Report Number
- 6000089-2005-00917
- Event Type
- Injury
- Date Received
- June 17, 2005
- Date of Event
- May 19, 2005
- Report Date
- May 19, 2005
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- FGE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PTA/STENTING TREATMENT PROCEDURE, THE EXPRESS2 STENT CAME OFF THE BALLOON. THE PHYSICIAN USED TWO OTHER STENTS TO SECURE THE EXPRESS2 STENT AGAINST THE VESSEL WALL.
Description of Event or Problem · 1
REQUEST FOR ADDITIONAL INFORMATION REGARDING THIS COMPLAINT HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM | EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM | FGE | BOSTON SCIENTIFIC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other| R |