BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVANCE

    MDR report key: 7477794 · Received May 1, 2018

    Report

    Report Number
    1220452-2018-00043
    Event Type
    Death
    Date Received
    May 1, 2018
    Date of Event
    November 14, 2017
    Report Date
    May 1, 2018
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K152335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AUTHOR: HONG-SEOK LIM, SANG SIK CHUNG JOURNAL: CIRCULATION YEAR: 2017 ISSUE: 2017;136:A19939 TITLE: EFFICACY OF THROMBO-SUCTION IN PRIMARY PERCUTANEOUS CORONARY INTERVENTION OF ACUTE MYOCARDIAL INFARCTION (ETAMI): KOREAN PROSPECTIVE RANDOMIZED MULTICENTER TRIAL LITERATURE REFERENCE: NCT01156662. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE JOURNAL ARTICLE REPORTS THAT THE EFFICACY AND SAFETY OF THROMBUS ASPIRATION DURING P-PCI IN STEMI PATIENTS, HAS NOT BEEN EVALUATED IN SECOND GENERATION DRUG-ELUTING STENT (DES) ERA. THE AUTHORS AIM TO INVESTIGATE WHETHER THE ROUTINE THROMBECTOMY DURING PRIMARY PERCUTANEOUS CORONARY INTERVENTION (P-PCI) IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) IMPROVE CLINICAL OUTCOMES. CULPRIT LESIONS INCLUDE LAD AND NON-LAD LESIONS. A TOTAL OF 1,335 PATIENTS WITH STEMI UNDERGOING P-PCI WERE ENROLLED AND RANDOMLY ASSIGNED AT A 1:1 RATIO BY WEB-BASED ALLOCATION METHOD TO MANUAL THROMBECTOMY USING THE EXPORT ASPIRATION CATHETER (EXPORT AP, EXPORT XT AND EXPORT ADVANCE), FOLLOWED BY PCI OR TO PCI WITH A SECOND GENERATION ZOTAROLIMUS-ELUTING STENT ONLY (ENDEAVOR RESOLUTE OR RESOLUTE INTEGRITY). SIX-HUNDRED SEVENTY-ONE (671) PATIENTS WERE ASSIGNED TO THROMBUS ASPIRATION. SIX-HUNDRED SIXTY-FOUR (664) PATIENTS WERE ASSIGNED TO CONVENTIONAL PCI. THE PRIMARY OUTCOME WAS 1-YEAR MAJOR ADVERSE CARDIAC EVENTS (MACE), A COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION (MI) AND TARGET VESSEL REVASCULARIZATION (TVR), AND STROKE. THE ARTICLE CONCLUDED THAT IN STEMI PATIENTS, ROUTINE THROMBUS ASPIRATION AS AN ADJUNCTIVE TREATMENT BEFORE P-PCI DID NOT REDUCE THE RATE OF MACE AT 1 YEAR AS COMPARED WITH PCI ALONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320225 ADVANCE CATHETER, EMBOLECTOMY DXE MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death