FDA Adverse Event
Injury
Summary report: N
LIFESTENT VASCULAR STENT SYSTEM
MDR report key: 3596536
·
Received January 16, 2014
Report
- Report Number
- 9681442-2014-00013
- Event Type
- Injury
- Date Received
- January 16, 2014
- Report Date
- December 20, 2013
- Manufacturer
- ANGIOMED GMBH AND CO. MEDIZINTECHNIK KG
- Product Code
- NIP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE U.S., THIS EVENT IS BEING REPORTED UNDER REGULATION 21CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE U.S. UNDER # P070014. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE SUBJECT DEVICE HAS NOT BEEN PROVIDED TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT SIX MONTHS POST IMPLANTATION OF A VASCULAR STENT, THE STENT WAS FOUND TO BE FRACTURED AND OCCLUDED. AN INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43825 | LIFESTENT VASCULAR STENT SYSTEM | VASCULAR STENT | NIP | ANGIOMED GMBH AND CO. MEDIZINTECHNIK KG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |