BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXPORT AP ASPIRATION CATHETER

    MDR report key: 8073479 · Received November 15, 2018

    Report

    Report Number
    1220452-2018-00134
    Event Type
    Death
    Date Received
    November 15, 2018
    Date of Event
    July 2, 2018
    Report Date
    November 15, 2018
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K120808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LIT REF: HTTPS://DOI.ORG/10.1016/J.JACC.2018.07.047. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE BENEFIT OF THROMBUS ASPIRATION AMONG STEMI PATIENTS WITH HIGH THROMBUS BURDEN. THE TOTAL TRIAL WAS A PROSPECTIVE, RANDOMIZED, INVESTIGATOR-INITIATED TRIAL OF ROUTINE MANUAL THROMBECTOMY WITH THE EXPORT CATHETER PLUS PCI VERSUS PCI ALONE IN PATIENTS WITH STEMI. PATIENTS WERE RANDOMIZED IN A 1:1 FASHION TO EITHER ROUTINE THROMBUS ASPIRATION WITH PCI OR PCI ALONE. THE PRIMARY OUTCOME WAS THE COMPOSITE OF CARDIOVASCULAR (CV) DEATH, RECURRENT MI, CARDIOGENIC SHOCK, OR CLASS IV HEART FAILURE AND THE KEY SAFETY OUTCOME WAS STROKE. IN PATIENTS WITH HIGH THROMBUS BURDEN, THROMBECTOMY DURING PRIMARY PCI FOR STEMI DID NOT REDUCE CV DEATH, MI, CARDIOGENIC SHOCK, OR CLASS IV HEART FAILURE COMPARED WITH PCI ALONE. HOWEVER, THROMBECTOMY WAS ASSOCIATED WITH A SIGNIFICANT INCREASE IN STROKE IN PATIENTS WITH HIGH THROMBUS BURDEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913289 EXPORT AP ASPIRATION CATHETER CATHETER, EMBOLECTOMY DXE MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death