FDA Adverse Event
Malfunction
Summary report: N
LIFESTENT VASCULAR STENT SYSTEM
MDR report key: 2504082
·
Received March 6, 2012
Report
- Report Number
- 9681442-2012-00026
- Event Type
- Malfunction
- Date Received
- March 6, 2012
- Report Date
- February 9, 2012
- Manufacturer
- ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
- Product Code
- NIP
- PMA / PMN Number
- P070014
- 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 UNKNOWN. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE STENT REMAINS IMPLANTED. THE DELIVERY SYSTEM WAS DISCARDED BY THE USER FACILITY. THEREFORE, SAMPLE EVALUATION COULD NOT BE PERFORMED. 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 SIX MONTHS POST STENT PLACEMENT, THE PATIENT PRESENTED WITH PAIN AND IMAGING DEMONSTRATED THE STENT HAD FRACTURED. INTERVENTION WAS PERFORMED. ADDITIONAL INFORMATION PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESTENT VASCULAR STENT SYSTEM | NIP | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |