FDA Adverse Event
Injury
Summary report: N
SMART CONTROL NITINOL STENT SYSTEM
MDR report key: 1111937
·
Received August 11, 2008
Report
- Report Number
- 9616099-2008-01966
- Event Type
- Injury
- Date Received
- August 11, 2008
- Date of Event
- June 21, 2006
- Report Date
- July 14, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- FGE
- PMA / PMN Number
- K021898
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
THE REPORT RECEIVED FROM THE STUDY INDICATED THAT A REVIEW OF A DIAGNOSTIC ULTRASOUND (DUS) ONE YEAR AFTER THE INDEX PROCEDURE BY THE CORE LAB INDICATED RESTENOSIS WAS OBSERVED IN STENT NUMBER ONE, PROXIMAL TO THE LESION SITE. A SMART 7 X 100 MM STENT WAS IMPLANTED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) DURING THE INDEX PROCEDURE. THE RELATIONSHIP OF THE ADVERSE EVENT TO THE STUDY DEVICE/PROCEDURE WAS NOT AVAILABLE. NO ADDITIONAL INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMART CONTROL NITINOL STENT SYSTEM | SELF EXPANDING STENTS (FGE) | FGE | CORDIS DE MEXICO | NA | 41104791 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization |