FDA Adverse Event
Injury
Summary report: N
PRECISE OTW NITINOL STENT
MDR report key: 1062917
·
Received June 19, 2008
Report
- Report Number
- 9616099-2008-01553
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- May 27, 2008
- Report Date
- May 26, 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
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
Description of Event or Problem · 1
THE MALE PT HAD A CAROTID ARTERY STENTING PROCEDURE IN LATE 2007. A 9 X 40 PRECISE STENT WAS IMPLANTED. THERE WAS NO INFO ABOUT THE TARGET VESSEL. PT HAD A TRANSIENT ISCHEMIC ATTACK AFTER THE INDEX PROCEDURE AND BECAME BLIND. NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISE OTW NITINOL STENT | SELF EXPANDING STENTS (NIM) | NIM | CORDIS DE MEXICO | NA | 13285621 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Life Threatening | ANGIOGUARD EMBOLIC PROTECTION DEVICE |