FDA Adverse Event
Injury
Summary report: N
SMART CONTROL NITINOL STENT SYSTEM
MDR report key: 1120794
·
Received August 15, 2008
Report
- Report Number
- 9616099-2008-02002
- Event Type
- Injury
- Date Received
- August 15, 2008
- Date of Event
- April 11, 2008
- Report Date
- July 22, 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
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2008-02001. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
Description of Event or Problem · 1
THE 62 YEAR-OLD MALE PATIENT RECEIVED TWO SMART CONTROL STENTS IN THE LEFT SFA. OVER A YEAR AND A HALF LATER, THE PATIENT HAD LEFT SFA RESTENOSIS IN BOTH STENTS. PATIENT WAS TREATED WITH DRUG THERAPY.
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 | 13071009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R | ASPIRIN |