BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAPAMYCIN CLINICAL 3.0X18MM

    MDR report key: 832036 · Received March 19, 2007

    Report

    Report Number
    9610978-2007-00167
    Event Type
    Death
    Date Received
    March 19, 2007
    Date of Event
    November 27, 2006
    Report Date
    March 8, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RAPAMYCIN CLINICAL STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE CORDIS CLINICAL STUDY SITE INDICATED THAT A PATIENT WAS FOUND DEAD IN THE NURSING HOME TWO WEEKS SHY FROM FOUR YEARS AFTER RECEIVING A CYPHER DRUG ELUTING STENT. AN AUTOPSY REPORT WAS NOT PERFORMED AND THE CAUSE OF DEATH IS NOT KNOWN. THE DRUG ELUTING STENT WAS IMPLANTED IN 2002 IN THE PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY. A VISUAL ESTIMATE OF THE TARGET LESION WAS 20MM BY 2.88MM WITH MODERATE TORTUOSITY, 65% STENOSIS AND A TIMI FLOW OF 3. THERE WAS NO REPORT OF CALCIFICATION. THE STENT WAS DEPLOYED AT 12ATM; PRE-STENTING ANGIOPLASTY AND POST DILATION WERE NOT PERFORMED. THE VISUAL ESTIMATE OF STENOSIS WAS 15% WITH A TIMI FLOW OF 3. THE PATIENT WAS DISCHARGED HOME ON ASPIRIN AND PLAVIX. IT IS NOT KNOWN WHETHER THE PATIENT HAD ANY ANGIOGRAMS OR STRESS TESTS AFTER THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPAMYCIN CLINICAL 3.0X18MM CORONARY SDS/STENTS (MAF) MAF CORDIS EUROPA, N.V. NA R0501722

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death