FDA Adverse Event
Injury
Summary report: N
LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM
MDR report key: 1901506
·
Received November 12, 2010
Report
- Report Number
- 9681442-2010-00111
- Event Type
- Injury
- Date Received
- November 12, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 1, 2010
- Manufacturer
- ANGIOMED GMBH & CO. MEDIZINTECHNIK
- Product Code
- NIP
- PMA / PMN Number
- P070014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER WAS UNK. THE STENT REMAINS IMPLANTED; THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST IMPLANT OF TWO OVERLAPPING STENTS IN THE SFA, IMAGING IDENTIFIED THAT ONE OF THE STENTS WAS TWISTED AND TO STRUTS APPEARED TO BE FRACTURED. REPORTEDLY, PTA WAS PERFORMED AND ANOTHER STENT WAS DEPLOYED. THE PT WAS REPORTED TO BE DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM | NIP | ANGIOMED GMBH & CO. MEDIZINTECHNIK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |