FDA Adverse Event
Injury
Summary report: N
LIFESTENT XL VASCULAR STENT
MDR report key: 2068406
·
Received April 13, 2011
Report
- Report Number
- 9681442-2011-00014
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 2011
- Manufacturer
- ANGIOMED GMBH & CO. MEDIZINTECHNIK
- Product Code
- NIP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO PMA # P070014 MARKETED IN THE UNITED STATES. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT APPROXIMATELY TWO DAYS AFTER THE STENT WAS IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY, THE STENT HAD OCCLUDED. REPORTEDLY, THE STENT WAS OBSERVED TO BE FORESHORTENED DURING THE INITIAL IMPLANT PROCEDURE AND POST-STENT DILATATION WAS NOT PERFORMED; HOWEVER, THERE WAS GOOD FLOW SEEN THROUGH THE VESSELS AT THE END OF THE PROCEDURE. A SURGICAL BYPASS PROCEDURE IS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESTENT XL VASCULAR STENT | NIP | ANGIOMED GMBH & CO. MEDIZINTECHNIK | ANVA0537 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |