FDA Adverse Event
Malfunction
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 1170724
·
Received September 15, 2008
Report
- Report Number
- 9616099-2008-02243
- Event Type
- Malfunction
- Date Received
- September 15, 2008
- Date of Event
- August 14, 2008
- Report Date
- August 21, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS PRODUCT IS SIMILAR TO US CYPHER. THIS IS THE FIRST OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT #9616099-2008-02242.
Description of Event or Problem · 1
DURING THE PROCEDURE TWO CYPHERS HAVE BEEN IMPLANTED FROM DISTAL LEFT INTERNAL MAMMARY ARTERY (LIMA) TO THE NATIVE LEFT ANTERIOR DESCENDING ARTERY, BUT THE CYPHER SEEMS FRACTURED ON THE OVERLAPPED PART IN THE LEFT INTERNAL MAMMARY ARTERY. THE LOT NUMBERS WERE NOT AVAILABLE, BECAUSE THE STENTS WERE IMPLANTED IN ANOTHER HOSPITAL A FEW YEARS AGO.
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 |