FDA Adverse Event
Other
Summary report: N
LIFESTENT NT SELF EXPANDING BILIARY STENT AND DELIVERY SYSTE
MDR report key: 726178
·
Received June 12, 2006
Report
- Report Number
- 6000002-2006-00337
- Event Type
- Other
- Date Received
- June 12, 2006
- Date of Event
- May 15, 2006
- Report Date
- May 15, 2006
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H6: DEVICE NOT RETURNED.
Description of Event or Problem · 1
THIS STENT REPORTEDLY USED IN SFA WITH RT COMMON FEMORAL STICK, WITH A CONTRALTERAL APPROACH, PLACED STENT DISTALLY IN LEFT SFA. NOTICED ON ANGIOGRAM THAT THE STENT HAD COMPRESSED TO 40 MM. A SECOND STENT WAS DEPLOYED TO GET COMPLETE COVERAGE OF THE LESION. SECOND STENT WAS DEPLOYED TO GET COMPLETE COVERAGE OF THE LESION. SECOND STENT WAS PLACED MID TO PROXIMAL. NO PT PERMANENT INJURY REPORTED. STENT WAS BEING USED OFF LABEL AS ITS APPROVED FOR USE IN THE BILIARY TREE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESTENT NT SELF EXPANDING BILIARY STENT AND DELIVERY SYSTE | BILIARY STENT | FGE | EDWARDS LIFESCIENCES | NT356602D | SE5G0085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |