FDA Adverse Event
Malfunction
Summary report: N
E-LUMINEXX VASCULAR STENT
MDR report key: 2240868
·
Received August 5, 2011
Report
- Report Number
- 9681442-2011-00043
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 11, 2011
- Report Date
- July 15, 2011
- Manufacturer
- ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
- Product Code
- NIO
- PMA / PMN Number
- P080007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE STENT REMAINS IMPLANTED, THEREFORE A SAMPLE EVAL COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT TWO YEARS AFTER IMPLANT IN A BILIARY LOCATION, A STENT FRACTURE WAS IDENTIFIED. ADD'L INFO PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | E-LUMINEXX VASCULAR STENT | NIO | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG | ANTE0360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |