BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1083538 · Received July 28, 2008

    Report

    Report Number
    9616099-2008-01872
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 3, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    STENT DISLODGEMENT. THE REPORT RECEIVED INDICATED THAT DURING A CORONARY PROCEDURE, THE PHYSICIAN WAS USING A 2.75 X 33MM CYPHER SELECT, THE TARGET LESION HAD BEEN SUCCESSFULLY PRE-DILATED; HOWEVER, WHILE ADVANCING THE CYPHER, THE PHYSICIAN FELT RESISTANCE WITH THE VESSEL AND DECIDED TO RETRIEVE THE STENT AND RE-ADVANCED. HOWEVER, THE STENT DISLODGED INSIDE THE PT, THE PHYSICIAN USED A 1.5MM PROFILE BALLOON TO TRY TO CROSS THE STENT, BUT THE STENT STILL DID NOT REACH THE LESION AND WAS DEPLOYED. THE STENT WAS DEPLOYED APPROX. 10-15MM FROM THE LESION. THE TARGET LESION WAS TREATED USING A COMPETITOR'S STENT. FURTHER INFO INDICATED THAT THE TARGET VESSEL WAS THE LEFT CIRCUMFLEX (LCX), THE LESION WAS CALCIFIED, TORTUOUS AND PRESENTED 90% STENOSIS. DURING THE PROCEDURE, THERE WAS NO EXCESSIVE FORCE; HOWEVER, IT WAS INDICATED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE BETWEEN THE STENT AND LESION AND SINCE THE LESION WAS HIGHLY CALCIFIED AND TORTUOUS IT COULD HAVE CONTRIBUTED TO THE DISLODGEMENT. PRIOR TO USE, THE DEVICE WAS INSPECTED AND PREPPED AS PER THE INSTRUCTIONS FOR USE. THERE WERE NO ANOMALIES IDENTIFIED.

    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 13386767

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention