FDA Adverse Event
Malfunction
Summary report: N
LIFESTENT FLEXSTAR XL VASCULAR STENT
MDR report key: 1941146
·
Received December 9, 2010
Report
- Report Number
- 9681442-2010-00117
- Event Type
- Malfunction
- Date Received
- December 9, 2010
- Date of Event
- October 20, 2010
- Report Date
- November 3, 2010
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- NIP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY UNDERWAY. THE DELIVERY SYSTEM HAS BEEN RECEIVED AT THE MANUFACTURING SITE AND IS CURRENTLY BEING EVALUATED. 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 THERE WAS DIFFICULTY DEPLOYING THE STENT IN A HEAVILY STENOSED SFA AND AFTER THE STENT WAS DEPLOYED, IT WAS OBSERVED TO HAVE ELONGATED APPROXIMATELY 8CM. THERE WAS NO REPORT OF INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESTENT FLEXSTAR XL VASCULAR STENT | NIP | BARD PERIPHERAL VASCULAR, INC. | ANUF1619 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |