BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1041275 · Received May 9, 2008

    Report

    Report Number
    9616099-2008-01256
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVAL AND TESTING; HOWEVER, AS OF TO DATE THE EVALUATION HAS NOT BEEN COMPLETED. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    BALLOON BURST DURING STENT DEPLOYMENT. THE REPORT RECEIVED INDICATED THAT DURING A STENTING PROCEDURE, THE PHYSICIAN PREDILATED THE LESION. THEN THE 3.0X13MM CYPHER WAS DELIVERED TO THE TARGET LESION, DURING INFLATION, THE BALLOON RUPTURED AT 14 ATMOSPHERES. A CORONARY ANGIOGRAM WAS CONDUCTED AND THE PHYSICIAN NOTICED THAT CONTRAST MEDIUM LEAKED FROM THE BALLOON AREA. THE DEVICE WAS REMOVED FROM THE PT WITHOUT ANY DIFFICULTIES; POST-DILATION WAS NOT CONDUCTED BECAUSE THE STENT DEPLOYMENT WAS SUFFICIENT. THE PROCEDURE WAS SAFELY FINISHED WITHOUT ANY INJURY OR ADVERSE EVENT TO THE PATIENT. FURTHER INFO INDICATED THAT THERE WERE NO OTHER ANOMALIES NOTED IN THE DEVICE AND NO OTHER PROBLEMS WERE ENCOUNTERED DURING THE PROCEDURE. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING, THE LESION WAS AN IN-STENT RESTENOSIS OF A NON-CORDIS STENT, AND THE LESION WAS FURTHER DESCRIBED AS HEAVILY CALCIFIED WITHOUT TORTUOUSITY AND PRESENTING 90% STENOSIS.

    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 13357183

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR SPEEDER 2.5/20MM BALLOON CATHETER| ENCORE INFLATION DEVICE| RUNTHROUGH GUIDE WIRE AND