BEUDAMED
    FDA Adverse Event Death Summary report: N

    J & J

    MDR report key: 515447 · Received March 11, 2004

    Report

    Report Number
    515447
    Event Type
    Death
    Date Received
    March 11, 2004
    Date of Event
    February 27, 2004
    Report Date
    March 3, 2004
    Manufacturer
    CORDIS
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT TRANSFERRED FROM ANOTHER HOSP WITH AMI, HAD REC'D TNK BUT FULLY REPERFUSED. TO THE CATH LAB-CYPHER STENT TO POSTERIOR LAD & RCA. HEPARIN & INTEGRILIN GIVEN. PT DEVELOPED RIGHT GROIN HEMATOMA, SO INTEGRILIN STOPPED. TO ICU THEN FULL ARREST WITHIN 1HR. RETURNED TO CATH LAB-BOTH STENTS CLOTTED-PTCA ATTEMPTED, MAXIMAL SUPPORT (CPR, IABP, MULTIPLE DRIPS) UNABLE TO RESUSCITATE - PT, EXPIRED. (2ND CATH CASE WAS PERFORMED WITH CPR. CPR IN PROGRESS THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J & J CYPHER DES RCA NIQ CORDIS CSX 18350-RCA X1203659
    2 J & J CYPHER DES LAD NIQ CORDIS CXS 33350-LAD A0104173

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death