BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX

    MDR report key: 8478513 · Received April 3, 2019

    Report

    Report Number
    9612164-2019-01146
    Event Type
    Death
    Date Received
    April 3, 2019
    Date of Event
    September 7, 2018
    Report Date
    April 3, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DUAL ANTIPLATELET THERAPY DURATION DETERMINES OUTCOME AFTER 2- BUT NOT 1-STENT STRATEGY IN LEFT MAIN BIFURCATION PERCUTANEOUS CORONARY INTERVENTION HTTPS://DOI.ORG/10.1016/J.JCIN.2018.09.020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS SUBMITTED THAT DOCUMENTED A STUDY WHERE 273 RESOLUTE INTEGRITY CORONARY DES, ENDEAVOR RESOLUTE CORONARY DES AND ENDEAVOR CORONARY DES WERE AMONG A NUMBER OF DES STENTS IMPLANTED IN A STUDY POPULATION OF 700 TO INVESTIGATE THE CLINICAL OUTCOMES AFTER LEFT MAIN CORONARY ARTERY (LM) BIFURCATION PERCUTANEOUS CORONARY INTERVENTION (PCI) AND THE IMPACT OF THE DURATION OF DUAL ANTIPLATELET THERAPY (DAPT) ACCORDING TO TREATMENT STRATEGY. TARGET LESIONS CHARACTERISTICS WERE BIFURCATION LESIONS, THREE VESSEL DISEASE, SEVERE CALCIFICATION WITH IN STENT RESTENOSIS. PROCEDURAL TECHNIQUES INCLUDED 1 STENT WITH PROVISIONAL SIDE BRANCH BALLOONING AND 2-STENT TECHNIQUE INCLUDING CRUSH TECHNIQUE, T-STENTING OR TAP, CULOTTE TECHNIQUE AND HIGH PRESSURE POST-DILATION WITH FINAL KISSING BALLOON TECHNIQUE WAS PERFORMED. CLINICAL EVENTS REPORTED IN THE PATIENTS TREATED WITH THESE DEVICES INCLUDED ALL-CAUSE DEATH, CARDIAC DEATH, ALL -CAUSE MI, TARGET VESSEL MI, REPEAT REVASCULARISATION, CLINICALLY DRIVEN TVR, CLINICALLY DRIVEN TLR, DEFINITE OR PROBABLE STENT THROMBOSIS, IN STENT RESTENOSIS AND HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271555 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death CLOPIDOGREL AND ASPIRIN