BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXPORT AP ASPIRATION CATHETER

    MDR report key: 7085305 · Received December 5, 2017

    Report

    Report Number
    1220452-2017-00122
    Event Type
    Death
    Date Received
    December 5, 2017
    Date of Event
    February 13, 2017
    Report Date
    December 5, 2017
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K120808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE REFERENCE: DOI: 10.1002/CCD.26959. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE STUDY'S OBJECTIVE WAS TO REVIEW THE EFFECTIVENESS OF MANUAL THROMBECTOMY (MT) IN A SERIES OF PATIENTS WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI), EXCLUSIVELY PRESENTING WITH TIMI 0-1 FLOW UNDERGOING PCI, IN ACCORDANCE TO THE ANGIOGRAPHICALLY ESTIMATED AREA AT RISK (AAR). THROMBECTOMY AT FIRST ATTEMPT WAS UNSUCCESSFUL IN NEARLY 15% OF CASES, NEEDING BALLOON PRE-DILATION TO ALLOW PASSAGE OF THE DEVICE, WHICH MAY HAVE LED TO THROMBUS MIGRATION. ON ADMISSION TO THE EMERGENCY ROOM, PATIENTS WERE LOADED WITH 300MG OF ASPIRIN AND 600MG OF CLOPIDOGREL, OR 180MG TICAGRELOR IF THEY WERE NOT ALREADY ON THESE MEDICATIONS. THROMBECTOMY WAS EXCLUSIVELY PERFORMED BY THE 6FR EXPORT CATHETER IN A CORONARY SEGMENT WITH TIMI 0-1 FLOW. VESSELS OPERATED ON INCLUDED THE LEFT ANTERIOR DESCENDING, THE LEFT CIRCUMFLEX, THE RIGHT CORONARY ARTERY, THE LEFT MAIN AND BY-PASS GRAFT. ANY IN-HOSPITAL DEATH WAS CONSIDERED FROM CARDIO-VASCULAR CAUSES UNLESS OTHER CAUSE WAS IDENTIFIED. A TOTAL OF 525 PATIENTS UNDERWENT MT. ONLY IN FIVE CASES MT WAS INCAPABLE OF CROSSING THE LESION DUE TO PROXIMAL TORTUOSITY, AND WAS CONSIDERED INEFFECTIVE. MACCE EVENTS INCLUDED RE-MI, DEATH, NEUROLOGICAL EVENTS IN THE CONTEXT OF BRAIN ANOXIA (PROFOUND HYPOTENSION AND/OR DURING RESUSCITATION EFFORTS) AND ISCHEMIC STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862142 EXPORT AP ASPIRATION CATHETER CATHETER, EMBOLECTOMY DXE MEDTRONIC, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death