BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGEO SEAL DEVICE

    MDR report key: 16683452 · Received April 4, 2023

    Report

    Report Number
    MW5116311
    Event Type
    Death
    Date Received
    April 4, 2023
    Date of Event
    February 21, 2023
    Report Date
    March 31, 2023
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AS A CODE STEMI ACTIVATION. PATIENT WAS TAKEN TO THE CATH LAB FOR EMERGENCY CORONARY ANGIOGRAM WHICH REVEALED 100% OCCLUDED MID CIRCUMFLEX FOR WHICH SHE UNDERWENT BALLOON ANGIOPLASTY, SHE WAS ALSO NOTED TO HAVE SIGNIFICANT LAD AND RCA STENOSIS. GIVEN POOR SURGICAL TARGET IN THE CIRCUMFLEX, STENTING WAS PERFORMED IN THE CIRCUMFLEX, FOLLOWED BY STENTING OF 80% LAD STENOSIS AND 99% RCA STENOSIS. FOLLOWING REVASCULARIZATION, PATIENT RECEIVED ANGIO-SEAL CLOSURE DEVICE BUT NOTED TO HAVE DEVELOPING HEMATOMA INDICATING CLOSURE DEVICE FAILURE. MANUAL COMPRESSION WAS APPLIED, DISTAL DPA PULSE WAS DOPPLER POSITIVE, PATIENT WAS TRANSFERRED TO ACU, AND GRADUALLY STARTED TO COMPLAIN OF RIGHT LOWER EXTREMITY NUMBNESS. ARTERIAL DUPLEX WAS ORDERED STAT WHICH REVEALED VERY SLOW MONOPHASIC WAVEFORM IN THE RIGHT SFA. PATIENT WAS TAKEN BACK FOR PERIPHERAL ANGIOGRAM WHICH REVEALED FILLING DEFECT IN THE RIGHT COMMON FEMORAL ARTERY SUSPICIOUS FOR DISSECTION, AND THE RIGHT SFA FILLING DEFECT. PATIENT UNDERWENT BALLOON ANGIOPLASTY, MECHANICAL THROMBECTOMY, BUT WAS ALSO NOTED TO HAVE SEVERE BELOW THE KNEE DISEASE. DISCUSSED WITH VASCULAR SURGERY, WHO DECIDED TO TAKE THE PATIENT TO THE OPERATING ROOM GIVEN HER WORSENING SYMPTOMS. PATIENT UNDERWENT RLE ILIOFEMORAL THROMBOENDARTERECTOMY AND REMOVAL OF INTRAVASCULAR FOREIGN BODY. HEPARIN WAS STOPPED AND PATIENT WAS TRANSFERRED TO THE ICU WHERE SHE CODED. PULSES RESTORED. PATIENT CODED AGAIN SHORTLY THEREAFTER AND THE PATIENT'S HUSBAND CHANGED HER STATUS TO COMFORT MEASURES AND SHE PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519686 ANGEO SEAL DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORP. 6FR

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Death