FDA Adverse Event
Injury
Summary report: N
PRECISE RX NITINOL STENT
MDR report key: 1101787
·
Received August 5, 2008
Report
- Report Number
- 9616099-2008-01921
- Event Type
- Injury
- Date Received
- August 5, 2008
- Date of Event
- April 14, 2008
- Report Date
- July 10, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
Description of Event or Problem · 1
THE PT HAD A PRECISE RX STENT PLACED IN THE RIGHT DISTAL COMMON CAROTID IN 2007. IN 2008, THE PT HAD A STROKE (INTRACEREBRAL/SUBARACHNOID HEMORRHAGE). THE ONSET WAS SUDDEN. THE PT HAD LEFT SIDE HEMIPARESIS AND HEMITAXIA. EMERGENCY CEA SURGERY WAS CONDUCTED AND THE NEUROLOGICAL DEFICIT WAS PERMANENT, WITH PARTIAL, MINOR RESIDUAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISE RX NITINOL STENT | SELF EXPANDING STENTS (NIM) | NIM | CORDIS DE MEXICO | NA | 13231568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization| R | CLOPIDOGREL| ASPIRIN |