BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1132343 · Received August 20, 2008

    Report

    Report Number
    3003742446-2008-00160
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    June 10, 2008
    Report Date
    July 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A CORONARY STENTING PROCEDURE, A CYPHER STENT DISLODGED. THE STENT WAS NOT RETRIEVED BUT WAS "CRUSHED AGAINST THE WALL OF ANOTHER ARTERY WITH A BALLOON". NO ADVERSE EFFECTS TO THE PT WERE REPORTED. THE EVENT OCCURRED DURING AN ATTEMPT TO ADVANCE THE CYPHER PAST A PREVIOUSLY DEPLOYED STENT IN A SAPHENOUS VEIN GRAFT. THE PRODUCT WAS NOT RETURNED FOR EVAL. A REVIEW OF THE MFG RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. REVIEW OF THE LIMITED INFO AVAILABLE SUGGESTS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE CYPHER COULD NOT BE ADVANCED INTO A SAPHENOUS VEIN GRAFT TO THE CIRCUMFLEX, PAST AN ALREADY DEPLOYED STENT. WHEN THE STENT DELIVERY SYS WAS REMOVED FROM THE BODY, THERE WAS NO STENT OBSERVED. THE STENT WAS SEEN UNDER FLUOROSCOPY IN THE PROXIMAL GRAFT. THE STENT WAS CRUSHED AGAINST THE WALL OF ANOTHER ARTERY WITH A BALLOON.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention