BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1170698 · Received September 16, 2008

    Report

    Report Number
    9616099-2008-02257
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    April 21, 2008
    Report Date
    August 22, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PRIOR TO INSERTING CYPHER STENT INTO THE PATIENT, THE PHYSICIAN VISUALLY CONFIRMED THE STENT TO BE FLARED. THE TARGET LESION WAS THE DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS A DE NOVO, SLIGHTLY TORTUOUS BUT NOT CALCIFIED. THERE WAS 75% STENOSIS. PRIOR TO INSERTING CYPHER INTO THE PATIENT, THE PHYSICIAN VISUALLY CONFIRMED THE STENT TO BE FLARED. IT WAS UNKNOWN WHICH SIDE OF THE STENT BECAME FLARED. THE PRODUCT WAS REPLACED WITH ANOTHER CYPHER (SAME SHAPE), AND THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WAS NOT CLINICALLY USED. THERE WAS NO REPORTED DAMAGE TO THE PACKAGING. THE PRODUCT WAS STORED PROPERLY.

    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 13349938

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GC: HEARTRAIL| GW: RUNTHROUGH| STENT: CYPHER (2.5/28MM)