BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1040293 · Received May 7, 2008

    Report

    Report Number
    3003742446-2008-00076
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 9, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD IS NOT AVAILABLE FOR EVAL, AS IT WAS IMPLANTED. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT REC'D INDICATED THAT DURING A CORONARY STENTING PROCEDURE, THE PHYSICIAN ADVANCED THE 2.5 X 18 MM CYPHER STENT, THE TARGET LESION WAS THE DISTAL POSTERIOR DESCENDING ARTERY (PDA) AND HAD SUCCESSFULLY BEING PREDILATED. HOWEVER, WHILE ADVANCING THE DEVICE THROUGH THE TORTUOUS, HIGHLY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA) THE PHYSICIAN ENCOUNTERED DIFFICULTIES DECIDED TO EXCHANGE THE DEVICE IN THE PROCESS OF REMOVING THE DEVICE, THROUGH THE HIGHLY CALCIFIED VESSEL, THE STENT DISLODGED IN THE PROXIMAL RCA. THE PHYSICIAN TRIED TO SNARE THE STENT AND ATTEMPTED TO DEPLOY THE STENT AT THE DISLODGED LOCATION WITHOUT ANY SUCCESS. THEREFORE, THE STENT WAS CRUSHED WITH ANOTHER STENT IN THE PROXIMAL RCA. THERE WERE NO OTHER COMPLICATIONS AND THE PT WAS DISCHARGED. THE LESION LENGTH WAS 15 MM AND WITH A 2.5 MM REFERENCE VESSEL DIAMETER. THE DISTAL PDA WAS DIFFUSED. THE ENTIRE VESSEL PRESENTED A CALCIFIED ANATOMY.

    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 13355963

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention PILOT 50 AL 2.0 SH