FDA Adverse Event
Malfunction
Summary report: N
SMART CONTROL NITINOL STENT SYSTEM
MDR report key: 1003393
·
Received February 20, 2008
Report
- Report Number
- 9616099-2008-00406
- Event Type
- Malfunction
- Date Received
- February 20, 2008
- Date of Event
- January 23, 2008
- Report Date
- January 24, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIO
- PMA / PMN Number
- P020036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING ATTEMPTED STENTING OF A HEAVILY CALCIFIED, 100 PERCENT STENOSED RIGHT SFA, VIA A CONTRALATERAL APPROACH, THE SMART CONTROL SDS COULD NOT PASS THE BIFURCATION OF THE ILIAC ARTERY. THE PHYSICIAN WITHDREW THE SDS, AND FOUND THAT THE STENT WAS PARTIALLY EXPOSED (APPROXIMATELY 5MM) EVEN THOUGH THE LOCKING PIN WAS STILL IN PLACE. ANOTHER SMART CONTROL SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EFFECT TO PT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMART CONTROL NITINOL STENT SYSTEM | SELF EXPANDING STENTS (NIO) | NIO | CORDIS DE MEXICO | NA | 13298396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |