FDA Adverse Event Malfunction Summary report: N

CCYPHER SIROLIMUS-ELUTING CORONARY STENT

MDR report key: 1238674 · Received November 14, 2008

Report

Report Number: 9616099-2008-02635
Event Type: Malfunction
Date Received: November 14, 2008
Date of Event: October 21, 2008
Report Date: October 21, 2008
Manufacturer: CORDIS DE MEXICO
Product Code: NIQ
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 13451545 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE CRIMPING MACHINE PARAMETERS, RELATED ANOMALIES, FPI/LPI FOR CROSSING PROFILE AND STENT RETENTION AND MRR'S, WAS REVIEWED AND NO ANOMALIES WAS FOUND. THIS PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING, HOWEVER, THE FAILURE ANALYSIS REPORT IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

Description of Event or Problem · 1

REPORT RECEIVED INDICATED THE CYPHER STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE LESION. IN ADDITION THE STENT DISLODGED FROM THE BALLOON. DURING AN INTERVENTIONAL PROCEDURE THE SDS DID NOT CROSS THE MID RIGHT CORONARY ARTERY LESION. THE LESION WAS 95% CALCIFIED. THE PHYSICIAN TRIED TO CROSS AGAIN BUT REALIZED A DISLODGEMENT OF THE STENT FROM THE BALLOON. THE SDS WAS RETRIEVED SAFELY FROM THE PATIENT. ANOTHER CYPHER STENT WAS USED TO FINISH THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CCYPHER SIROLIMUS-ELUTING CORONARY STENT	DRUG-ELUTING STENT (NIQ)	NIQ	CORDIS DE MEXICO	NA	13451545

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK			7F JR 4 G/C GUIDING CATHETER\| CHOICE PT SGW