FDA Adverse Event
Injury
Summary report: N
LIFESTENT VASCULAR STENT
MDR report key: 2090107
·
Received May 6, 2011
Report
- Report Number
- 9681442-2011-00018
- Event Type
- Injury
- Date Received
- May 6, 2011
- Date of Event
- March 24, 2011
- Report Date
- March 25, 2011
- Manufacturer
- ANGIOMED GMBH & CO. MEDIZINTECHNIK
- Product Code
- NIP
- PMA / PMN Number
- P070014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER FOR THE DEVICE IS UNK; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE CONDUCTED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT APPROXIMATELY NINE MONTHS POST-IMPLANT, ANGIOGRAPHY DEMONSTRATED THAT THE STENT WAS FRACTURED AND OCCLUSION WITHIN THE STENT AND VESSEL WAS IDENTIFIED. REINTERVENTION IS PLANNED. THERE WAS NO REPORT OF INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESTENT VASCULAR STENT | NIP | ANGIOMED GMBH & CO. MEDIZINTECHNIK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |