FDA Adverse Event
Injury
Summary report: N
SMART CONTROL NITINOL STENT SYSTEM
MDR report key: 1040536
·
Received May 9, 2008
Report
- Report Number
- 9616099-2008-01264
- Event Type
- Injury
- Date Received
- May 9, 2008
- Date of Event
- April 15, 2008
- Report Date
- April 15, 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
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE SAME PRODUCT DISTRIBUTED IN THE UNITED STATES. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
Description of Event or Problem · 1
THE PT SUFFERED AN INSTENT RESTENOSIS OF 75%, WHICH WAS TREATED WITH PTA AND PLACEMENT OF A STENT PROXIMAL AND DISTAL TO THE PREVIOUSLY PLACED STENT.
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 | 13256442 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention |