FDA Adverse Event
Death
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 1220331
·
Received November 4, 2008
Report
- Report Number
- 9616099-2008-02598
- Event Type
- Death
- Date Received
- November 4, 2008
- Date of Event
- October 6, 2008
- Report Date
- October 6, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT HAD A CORONARY INTERVENTION IN WHICH THREE DRUG-ELUTING STENTS WERE IMPLANTED (TWO NON-CORDIS AND ONE CYPHER) AND TWO HOURS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A MASSIVE MYOCARDIAL INFARCTION. THE PATIENT EXPIRED AFTER MANY RESUSCITATION TECHNIQUES WERE PERFORMED.
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 | UNK | Death |