BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPORT AP ASPIRATION CATHETER

    MDR report key: 8455137 · Received March 27, 2019

    Report

    Report Number
    1220452-2019-00034
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    December 10, 2018
    Report Date
    March 27, 2019
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K120808
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LIT REF: DOI.ORG/10.1186/S12872-018-0951-9. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED TO HOSPITAL WITH SEVERE CHEST PAIN LASTING 2 H. BLOOD PRESSURE WAS 130/80 MMHG ON ADMISSION, AND PRESENTED WITH NO LATERALITY IN THE UPPER EXTREMITIES. ELECTROCARDIOGRAPHY ON ARRIVAL SHOWED ST-SEGMENT ELEVATION. PATIENT WAS DIAGNOSED WITH INFERIOR ST-SEGMENT ELEVATION MYOCARDIAL IN-FARCTION(STEMI) AND IMMEDIATELY BROUGHT TO THE CARDIAC CATHETERIZATION LABORATORY. AN EMERGENCY CORONARY ANGIOGRAPHY REVEALED A LARGE FILLING DEFECT EXTENDING FROM THE DISTAL LM ARTERY INTO THE PROXIMAL LCX ARTERY. OTHERWISE, NO SIGNIFICANT LESIONS WERE FOUND AND THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI)III FLOWS WERE OBSERVED IN ALL CORONARY ARTERIES. THEREFORE, PCI WAS PERFORMED USING A 6 FR GUIDING CATHETER(EBU3.5, MEDTRONIC). WHILE A 0.014-IN. NON-MEDTRONIC GUIDEWIRE CROSSED THE LM ARTERY, THE WHOLE THROMBUS WAS EXTRACTED FROM THE PROXIMAL LCX ARTERY AND PUSHED INTO THE LAD ARTERY. THE PROXIMAL LAD ARTERY WAS COMPLETELY OCCLUDED BY THE THROMBUS. AFTER CROSSING THE LESION IN THE LAD ARTERY WITH THE NON-MEDTRONIC GUIDEWIRE, THROMBECTOMY WAS ATTEMPTED SEVERAL TIMES USING AN ASPIRATION CATHETER (EXPORT, MEDTRONIC). HOWEVER, THESE TREATMENTS DID NOT REDUCE THE THROMBUS BURDEN IN THE PROXIMAL LAD ARTERY, AND NO VISIBLE THROMBUS WAS DETECTED IN THE ASPIRATE. THEN, A 14-ATM DILATION OF A NON-MEDTRONIC SEMI COMPLIANT BALLOON WAS PERFORMED IN THE LESION. HOWEVER, THE THROMBUS MOVED TO THE MIDDLE LAD ARTERY WITH TIMI FLOW 0. FOLLOWING THE FAILURE OF ANOTHER ATTEMPT OF ASPIRATION USING AN EXPORT CATHETER (MEDTRONIC), THROMBUS EXTRACTION FROM THE LAD ARTERY WAS CONSIDERED AS IMPOSSIBLE. THE INITIAL ANGIOGRAM SHOWED NO STENOSIS IN THE LAD ARTERY, WHICH HAD DIAMETERS ABOVE 2.5 MM AND ABOVE 1.5 MM AT THE DISTAL AND TERMINAL SITES, RESPECTIVELY. TO REDUCE THE INFARCT SIZE, THE THROMBUS WAS PUSHED TO THE TERMINAL LAD ARTERY. A DILATED NON-MEDTRONIC BALLOON WITH 6 ATM WAS USED TO PUSH THE THROMBUS CAREFULLY TOWARD THE DISTAL LAD ARTERY. FURTHERMORE, THE CONTRACTED NON-MEDTRONIC BALLOON WAS SUCCESSFULLY PUSHED THE THROMBUS TO THE TERMINAL LAD ARTERY. THE FINAL ANGIOGRAM DEMONSTRATED NO OTHER SIGNIFICANT STENOSIS EXCEPT THE EMBOLIZATION IN THE TERMINAL SITE OF THE LAD ARTERY; THUS, STENT DEPLOYMENT WAS NOT PERFORMED. THE PATIENT WAS TRANSFERRED TO THE CORONARY INTENSIVE CARE UNIT IN A HEMODYNAMICALLY STABLE CONDITION, WHILE ST ELEVATION SUBSIDED. PATIENT WAS STARTED ON MEDICATION. A FOLLOW-UP CORONARY ANGIOGRAPHY WAS PERFORMED 1 WEEK LATER, WHICH REVEALED THE RESTORATION OF TIMI 3 FLOW AND THE COMPLETE RESOLUTION OF THROMBUS IN THE LEFT CORONARY ARTERY. THE PATIENT HAD AN UNCOMPLICATED RECOVERY AND WAS DISCHARGED AFTER 2 DAYS. NO ADVERSE EVENTS OCCURRED DURING A 12-MONTH FOLLOW-UP PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248447 EXPORT AP ASPIRATION CATHETER CATHETER, EMBOLECTOMY DXE MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention