FDA Adverse Event
Malfunction
Summary report: N
SMART CONTROL NITINOL STENT SYSTEM
MDR report key: 1022094
·
Received March 25, 2008
Report
- Report Number
- 9616099-2008-00786
- Event Type
- Malfunction
- Date Received
- March 25, 2008
- Date of Event
- February 26, 2008
- Report Date
- February 28, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIO
- PMA / PMN Number
- P020036
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL THE INSTRUCTION FOR USE (IFU) GUIDELINES WAS UTILIZED DURING PREP, AND ATTEMPTED UTILIZATION OF THE PRODUCT. PRIOR TO SHIPPING, THERE WERE NO OTHER ISSUES WITH THE UNIT. THE PRODUCT WAS NOT UTILIZED IN THE PT. NO FURTHER INFO WAS AVAILABLE. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS.
Description of Event or Problem · 1
DURING PREPPING OF THE 6 X 100 MM SMART STENT, THE STENT STARTED AN INITIAL DEPLOYMENT PRIOR TO PLACING IN THE PT. THE EXPERIENCED PHYSICIAN CONSIDERED THE PRODUCT DEFECTIVE.
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 | 13333060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |