FDA Adverse Event
Injury
Summary report: N
SMART CONTROL NITINOL STENT SYSTEM
MDR report key: 1000036
·
Received February 14, 2008
Report
- Report Number
- 9616099-2008-00347
- Event Type
- Injury
- Date Received
- February 14, 2008
- Date of Event
- January 30, 2008
- Report Date
- January 30, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIO
- PMA / PMN Number
- P020036
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
WHILE THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE SMART CONTROL (C06100ML) INTO THE PT'S SUPERFICIAL FEMORAL ARTERY, THE STENT DID NOT FULLY DEPLOY. THE PHYSICIAN HAD TO BREAK THE SMART CONTROL HANDLE AND PULL THE SHEATH BACK IN ORDER TO DEPLOY THE STENT. THE STENT WAS DEPLOYED APPROPRIATELY PER FLUOROSCOPY REPORT. THE PT WAS ASYMPTOMATIC UPON THE PARTIAL DEPLOYMENT AND WAS IN NO DISTRESS. THERE WERE ADVERSE CONSEQUENCE TO FEMALE PT.
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 | 13320090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Required Intervention |