FDA Adverse Event
Injury
Summary report: N
LIFESTENT SOLO VASCULAR STENT SYSTEM
MDR report key: 3193521
·
Received June 25, 2013
Report
- Report Number
- 9681442-2013-00068
- Event Type
- Injury
- Date Received
- June 25, 2013
- Date of Event
- May 29, 2013
- Report Date
- June 3, 2013
- Manufacturer
- ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
- Product Code
- NIP
- PMA / PMN Number
- P070014/S038
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT HISTORY HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A VASCULAR STENT DEPLOYMENT IN THE SFA, THE VASCULAR STENT PARTIALLY DEPLOYED AND FRACTURED OFF FROM THE REMAINING DELIVERY SYSTEM. AN EXPANDABLE BALLOON STENT WAS USED TO PUSH THE STENT AGAINST THE SFA; ANOTHER VASCULAR STENT WAS PREPPED AND DEPLOYED SUCCESSFULLY TO COVER THE FRACTURED STENT IN REMAINING LESION. THERE IS NO REPORTED PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 287098 | LIFESTENT SOLO VASCULAR STENT SYSTEM | NIP | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG | ANWL2441 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |