FDA Adverse Event
Malfunction
Summary report: N
LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM
MDR report key: 1487877
·
Received August 10, 2009
Report
- Report Number
- 9681442-2009-00079
- 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 REPORTS # 9681442-2009-00080. 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 IN THE POPLITEAL ARTERY, THE STENT FRACTURED.
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 |