BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053640 · Received May 27, 2008

    Report

    Report Number
    3003742446-2008-00088
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 5, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION; HOWEVER, AS OF TO DATE IT HAS NOT BEEN RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    STENT OUT OF POSITION. THE REPORT RECEIVED INDICATED THAT DURING A CORONARY PROCEDURE, THE PHYSICIAN ADVANCED THE 2.75 X 18 MM CYPHER STENT DELIVERY SYSTEM (SDS); HOWEVER, THE PHYSICIAN ENCOUNTERED RESISTANCE DUE TO CALCIUM DEPOSITS IN THE VESSEL AND WHILE ATTEMPTING TO POSITION THE DELIVERY SYSTEM, THE STENT MOVED PROXIMALLY ON THE BALLOON. THE STENT DID NOT DISLODGE; INSTEAD, IT WAS OUT OF POSITION ON THE DELIVERY SYSTEM, WHILE STILL REMAINING ON THE BALLOON. AFTER ENCOUNTERING THE PROBLEM, THE PHYSICIAN RETRACTED THE SDS INTO THE GUIDE AND WAS REMOVED FROM THE PATIENT WITHOUT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH A TAXUS STENT. FURTHER INFORMATION INDICATED THE PROCEDURE INCLUDED TREATMENT OF A CALCIFIED AND HIGHLY STENOSED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE LESION LENGTH WAS 15 MM WITH A 2.5MM REFERENCE VESSEL DIAMETER. THE LESION HAD NOT BEEN PRE-DILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 13368636

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK