FDA Adverse Event
Malfunction
Summary report: N
LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM
MDR report key: 1487874
·
Received August 10, 2009
Report
- Report Number
- 9681442-2009-00080
- Event Type
- Malfunction
- Date Received
- August 10, 2009
- Date of Event
- January 19, 2009
- Report Date
- July 20, 2009
- Manufacturer
- ANGIOMED GMBH & CO. MEDIZINTECHNIK
- Product Code
- NIP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER WAS UNK. THE STENT REMAINS IMPLANTED; THEREFORE, NOT AVAILABLE FOR EVAL. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT IS ASSOCIATED WITH THE SAME PT IN THE EVENT REPORTED UNDER MFR REPORT NO 9681442-2009-00079. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES PMA# P070014.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER STENTING THE SFA, A DEFORMATION OR FRACTURE OF THE STENT OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM | NIP | ANGIOMED GMBH & CO. MEDIZINTECHNIK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |