FDA Adverse Event
Malfunction
Summary report: N
LIFESTENT SOLO VASCULAR STENT SYSTEM
MDR report key: 3030877
·
Received March 28, 2013
Report
- Report Number
- 9681442-2013-00031
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 5, 2013
- Manufacturer
- ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
- Product Code
- NIP
- PMA / PMN Number
- P070014/S035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 A VASCULAR STENT STARTED TO PREMATURELY DEPLOY; HOWEVER, THE STENT AND DELIVERY SYSTEM WERE RETRIEVED AS ONE UNIT WITHOUT INCIDENT. AN ADDITIONAL VASCULAR STENT WAS PREPPED AND DEPLOYED AT THE LESION SITE SUCCESSFULLY. THERE IS NO REPORTED PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128583 | LIFESTENT SOLO VASCULAR STENT SYSTEM | NIP | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG | ANWL0900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |