BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2180820 · Received July 21, 2011

    Report

    Report Number
    9612164-2011-00806
    Event Type
    Death
    Date Received
    July 21, 2011
    Date of Event
    February 2, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: (BASED ON THE INFORMATION PROVIDED, NO ROOT CAUSE CAN BE DETERMINED). (DEATH).

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RAPID EXCHANGE DRUG ELUTING STENTS WERE DEPLOYED IN THE LMCA, PROXIMAL LAD AND MID LAD TO TREAT 75% STENOSIS. THE PROCEDURE RESULTED IN 5% STENOSIS. ECG CHECK CONFIRMED THERE WERE NO ABNORMALITIES. DIAGONAL BRANCH WAS 99% STENOSED. HOWEVER, THE PHYSICIAN ELECTED NOT TO TREAT THE STENOSIS AS IT DID NOT HAVE A SIGNIFICANT IMPACT ON HEART FUNCTION. THE FOLLOWING DAY, THE PT SUFFERED CARDIAC ARREST. PERICARDIAL EFFUSIONS WERE CONFIRMED ON CT AND THE PT DIED. IT WAS SPECULATED THAT CARDIAC RUPTURE OCCURRED IN THE DIAGONAL BRANCH. THE INVESTIGATOR REPORTS THAT THERE IS NO CAUSAL RELATIONSHIP WITH THE PRODUCT, ZOTAROLIMUS OR PROCEDURE. REFERENCE MFR REPORT NUMBER 9612164-2011-00807.

    Description of Event or Problem · 1

    CLINICAL EVENT COMMITTEE (CEC) REPORTED THAT, STENT JAIL WAS CONFIRMED TO FIRST DIAGONAL BASED ON REVIEW OF CINE IMAGES. CEC ADJUDICATED THAT THE REPORTED EVENT WAS RELATED TO THE STUDY DEVICE AND PROCEDURE. REFERENCE MFR REPORT NUMBERS 9612164201100806 AND 9612164201100807.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death ASPIRIN| CLOPIDOGREL