BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2362680 · Received December 8, 2011

    Report

    Report Number
    9612164-2011-01618
    Event Type
    Death
    Date Received
    December 8, 2011
    Date of Event
    November 8, 2011
    Report Date
    November 29, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: INHERENT RISK OF PROCEDURE MYOCARDIAL INFARCTION. CONCLUSION: KNOWN INHERINT RISK OF PROCEDURE: MYOCARDIAL INFARCTION. (B)(4).

    Additional Manufacturer Narrative · 1

    CLOPIDOGREL AND ASA. (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (SHOCK/DEATH).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT SUFFERED AN MI APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE 1ST OBTUSE MARGINAL AND ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE 2ND OBTUSE MARGINAL. DURING A STAGED PROCEDURE 1 WEEK POST INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE PROXIMAL RCA AND ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE DISTAL RCA. APPROXIMATELY 4.5 MONTHS POST INDEX PROCEDURE, THE PATIENT WAS REHOSPITALIZED AND CABG OF THE RIGHT POSTERIOR DESCENDING ARTERY AND 1ST/2ND OBTUSE MARGINAL WAS PERFORMED DUE TO RESTENOSIS. PATIENT DEATH OCCURRED THREE DAYS POST CABG. CAUSE OF DEATH CARDIOGENIC SHOCK. THE INVESTIGATOR INDICATED THAT THE REPORTED CABG WAS DEFINITELY RELATED TO THE DEVICE. THE INVESTIGATOR INDICATED THAT THE PATIENT DEATH WAS UNLIKELY RELATED TO THE DEVICE. REF MFR# 9612164-2011-01618, 9612164-2011-01619, 9612164-2011-01620, 9612164-2011-01621

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE LCX AND ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE 2ND OBTUSE MARGINAL DURING INDEX PROCEDURE NOT ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE 1ST OBTUSE MARGINAL AND ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE 2ND OBTUSE MARGINAL AS PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005534967

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death| R BETA-BLOCKER, ACE, LIPID LOWERING DRUGS, CLOPIDOGR