FDA Adverse Event
Death
Summary report: N
PRECISE RX NITINOL STENT
MDR report key: 1111651
·
Received August 11, 2008
Report
- Report Number
- 9616099-2008-01954
- Event Type
- Death
- Date Received
- August 11, 2008
- Date of Event
- February 11, 2008
- Report Date
- August 22, 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
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
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 MALE PATIENT RECEIVED A PRECISE STENT IN THE LEFT INTERNAL CAROTID ARTERY. THE EMAIL RECEIVED FOR THE STUDY INDICATED THAT APPROXIMATELY 7 MONTHS POST-PROCEDURE, THE PATIENT DIED AT HOME WHILE RECEIVING HOME HOSPICE. THE EXACT CAUSE OF DEATH IS UNKNOWN.
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 | 13170998 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Death | ASPIRIN.| CLOPIDOGREL.| ASPIRIN| CLOPIDOGREL |