BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1004011 · Received February 26, 2008

    Report

    Report Number
    3003742446-2008-00029
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    December 17, 2007
    Report Date
    January 31, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLATED. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT APPROX ONE MONTH POST STENT IMPLANT, A CORONARY ANGIOGRAPHY SHOWED A FRACTURED STENT WITH RESTENOSIS. THE STENTING PROCEDURE INCLUDED TREATMENT OF A TYPE C LESION IN THE FIRST OBTUSE MARGINAL ARTERY. THE TARGET VESSEL PRESENTED EXCESSIVE TORTUOSITY AND WAS EXTREMELY ANGULATED. THE LESION LENGTH WAS 11 MM WITH A 3.0 MM REFERENCE VESSEL DIAMETER. DURING THE PROCEDURE, THE STENT WAS DEPLOYED TO 18 ATMOSPHERES, FOLLOWED BY POST DILATION. THE PROCEDURE WAS COMPLETED WITHOUT REPORT OF COMPLICATIONS. APPROX ONE MONTH AFTER THE STENTING PROCEDURE, A CORONARY ANGIOGRAM REVEALED THE STENT WAS COMPLETELY FRACTURED. ALTHOUGH, THERE WAS NO MIGRATION OF ANY OF THE FRACTURED SEGMENTS, THE FRACTURE WAS ASSOCIATED WITH RESTENOSIS, WHICH WAS TREATED WITH A 3.5 X 8 MM CYPHER STENT. THE PT WAS REPORTED TO BE IN GOOD CONDITIONS.

    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 13280135

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R