BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXPORT AP ASPIRATION CATHETER

    MDR report key: 7262776 · Received February 12, 2018

    Report

    Report Number
    1220452-2018-00013
    Event Type
    Death
    Date Received
    February 12, 2018
    Date of Event
    November 14, 2017
    Report Date
    May 1, 2018
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K120808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL HISTORY INCLUDED DIABETES, HYPERTENSION AND SMOKING. CULPRIT LESIONS INCLUDE LAD AND NON-LAD LESIONS. 671 PATIENTS WERE ASSIGNED TO THROMBUS ASPIRATION. 664 PATIENTS WERE ASSIGNED TO CONVENTIONAL PCI. EXPORT ASPIRATION CATHETERS USED INCLUDED EXPORT AP, EXPORT XT AND EXPORT ADVANCE. SECOND GENERATION ZOTAROLIMUS-ELUTING STENTS INCLUDED ENDEAVOR RESOLUTE OR RESOLUTE INTEGRITY. PATIENT OUTCOME ALSO INCLUDED STROKE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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: (B)(4). 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. 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, FOLLOWED BY PCI OR TO PCI WITH A SECOND GENERATION ZOTAROLIMUS-ELUTING STENT ONLY. THE PRIMARY OUTCOME WAS 1-YEAR MAJOR ADVERSE CARDIAC EVENTS (MACE), A COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION (MI) AND TARGET VESSEL REVASCULARIZATION (TVR). 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
    107690 EXPORT AP ASPIRATION CATHETER CATHETER, EMBOLECTOMY DXE MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death