FDA Adverse Event
Injury
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 1080165
·
Received July 21, 2008
Report
- Report Number
- 9616099-2008-01804
- Event Type
- Injury
- Date Received
- July 21, 2008
- Date of Event
- April 15, 2008
- Report Date
- June 26, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE (LOT UNK) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT #9616099-2008-01803. 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 MALE PT RECEIVED TWO CYPHER SELECT PLUS STENTS IN THE PROXIMAL TO MID LAD. ONE DAY POST PROCEDURE, THE PT HAD CHEST PAIN. THERE WERE NO ECG CHANGES, BUT CK-MB WAS RAISED AND THUS A MYOCARDIAL INFARCTION WAS DIAGNOSED. AT THE ONE MONTH FOLLOW-UP, THE PT HAD ANGINA PECTORIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS DE MEXICO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Life Threatening | CLOPIDOGREL| ASPIRIN |