BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1201533 · Received October 17, 2008

    Report

    Report Number
    3003742446-2008-00199
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 22, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A CORONARY INTERVENTION, A CYPHER STENT DISLODGED. THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT WITH A SERIES OF GRADUATED BALLOONS AND NO PATIENT INJURY OCCURRED. THE TARGET SITE IN THE DISTAL RCA WAS DESCRIBED AS CALCIFIED. THE VESSEL WAS TORTUOUS AND WHEN THE SDS REACHED THE PROXIMAL PORTION OF THE RCA, THE STENT DISLODGED. IT IS NOT KNOWN IF NEGATIVE PRESSURE WAS INDUCED ON THE SYSTEM PRIOR TO INTRODUCING IT INTO THE PATIENT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THIS LOT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT RETURN OF THE SDS. THE SAFETY AND EFFECTIVENESS OF CYPHER HAS NOT BEEN ESTABLISHED FOR USE IN PATIENTS WITH TORTUOUS VESSELS IN THE REGION OF OBSTRUCTION OR PROXIMAL TO THE LESION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL/LESION CHARACTERISTICS OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR A PROCEDURE IN 2008 WITH A CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY. THE VESSEL WAS NOTED TO BE TORTUOUS. A 3.0 X 28MM CYPHER STENT WAS CHOSEN FOR THE PROCEDURE. THE STENT WAS DELIVERED THROUGH THE GUIDING CATHETER WITHOUT ANY PROBLEMS AND WHEN THE STENT REACHED THE PROXIMAL PORTION OF THE RIGHT CORONARY, IT DISLODGED. THERE WAS NO RESISTANCE ENCOUNTERED WHILE DELIVERING THE STENT. THE STENT DELIVERY SYSTEM WAS WITHDRAWN AND A 1.5MM BALLOON WAS USED TO INFLATE THE STENT IN THE PROXIMAL RIGHT CORONARY. THEN THE BALLOON WAS REMOVED AND A 2.5MM BALLOON WAS USED TO INFLATE THE STENT SEVERAL TIMES TO ITS FULL CAPACITY. THE DISTAL RIGHT CORONARY WAS STENTED WITH A DIFFERENT PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    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 13457885

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention