FDA Adverse Event
Malfunction
Summary report: N
LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM
MDR report key: 1756761
·
Received June 22, 2010
Report
- Report Number
- 9681442-2010-00048
- Event Type
- Malfunction
- Date Received
- June 22, 2010
- Date of Event
- May 25, 2010
- Report Date
- May 25, 2010
- Manufacturer
- ANGIOMED GMBH & CO.
- Product Code
- NIP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT SAMPLE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY. 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 PRIOR TO REMOVAL OF THE SAFETY CLIP, THE STENT DEPLOYED APPROX 3 MM. THE ISSUE WAS IDENTIFIED UNDER FLUOROSCOPY. THE DEVICE WAS REMOVED FROM THE PT WITHOUT ANY INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM | NIP | ANGIOMED GMBH & CO. | 58603993 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |