BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY SYSTEM

    MDR report key: 1040381 · Received May 6, 2008

    Report

    Report Number
    9616099-2008-01237
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 9, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVAL AND TESTING. HOWEVER, AS OF TO DATE THE EVAL 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

    DURING THE PROCEDURE, THE METAL SHAFT OF THE DEVICE WAS BENT, THE PHYSICIAN REMOVED THE DEVICE FROM THE PT AND TRIED TO RESHAPE THE SHAFT BUT THE DEVICE BROKE. THE REPORT RECEIVED INDICATED THAT DURING A CORONARY STENTING PROCEDURE, THE TARGET LESION WAS SUCCESSFULLY PRE-DILITATED THEN THE PHYSICIAN INTRODUCED THE 2.50X33MM CYPHER IN THE PT AND WHEN THE PHYSICIAN TRIED TO ADVANCE THE STENT THROUGH THE VESSEL, THE PHYSICIAN ENCOUNTERED DIFFICULTIES TRACKING THE DEVICE TO THE LESION. THEREFORE, THE PHYSICIAN WITHDREW THE DEVICE FROM THE PT. NO DIFFICULTIES WERE ENCOUNTERED DURING REMOVAL. UPON WITHDRAWAL, THE PHYSICIAN CHECKED THE CATHETER AND FOUND THE METAL SHAFT WAS BENT AND CRACKED. THE PHYSICIAN TRIED TO RE-SHAPE THE SHAFT AND THE HYPOTUBE BROKE IN TWO PIECES. THE BREAKAGE OCCURED APPROXIMATELY, 30 CM FROM THE PROXIMAL END OF THE DEVICE. THE PHYSICIAN EXCHANGED THE DEVICE AND TO CONTINUE THE PROCEDURE, PRE-DILATATION WAS CONDUCTED AND A CYPHER STENT WAS DEPLOYED TO 20 ATMOSPHERES, TIMI FLOW POST PROCEDURE WAS II. THE PROCEDURE WAS PROLONGED FOR APPROXIMATELY 240 MINUTES; HOWEVER, IT WAS COMPLETED SUCCESSFULLY WITHOUT ANY INJURY ADVERSE EVENT TO THE PT. FURTHER INFO INDICATED THAT THE TARGET VESSEL WAS THE LEFT MAIN AND THE LEFT ANTERIOR DESCENDING. THE DE NOVO, TYPE B2 LESION WAS MODERATELY CALCIFIED, TORTUOUS AND PRESENTED A 70% STENOSIS. THE LESION LENGTH WAS 25MM. IT WAS INDICATED THAT WHILE TRACKING THE DEVICE TO THE LESION, THE PHYSICIAN USED SOME FORCE; HOWEVER, IT WAS NOT EXCESSIVE. THE PHYSICIAN CONSIDERED THE LESION WAS DIFFICULT TO TREAT WITH THE LEFT MAIN AND THE HIGH LEVEL OF CALCIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY SYSTEM DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 13349931

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR UNKNOWN GUIDING CATHETER| STEERABLE GUIDEWIRE| 2.0MM| PRE-DILATION BALLOON 1.5MM| 2.5MM