BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 15221994 · Received August 12, 2022

    Report

    Report Number
    3015053858-2022-00049
    Event Type
    Death
    Date Received
    August 12, 2022
    Report Date
    August 2, 2022
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS PUBLICATION WAS NOT RETURNED THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. BASED ON THE PROVIDED INFORMATION, THE PATIENT EXPIRED DUE TO FATAL IN-STENT THROMBOSIS THAT OCCURRED DURING THE IN-HOSPITAL PERIOD (FIVE DAYS AFTER A PCI). SHOCKWAVE MEDICAL, INC. HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED.

    Description of Event or Problem · 0

    PUBLICATION: 2022 ROLA INTRAVASCULAR LITHOTRIPSY AS A NOVEL TREATMENT METHOD FOR CALCIFIED UNPROTECTED LEFT MAIN DISEASES-COMPARISON TO ROTATIONAL ATHERECTOMY-SHORT-TERM OUTCOMES. A RETROSPECTIVE ANALYSIS OF A DATASET FROM A REGISTRY CONDUCTED IN TWO COOPERATIVE, HIGH-VOLUME PCI CARDIAC CENTERS. THE 15 SUBJECTS IN THIS STUDY WERE CAREFULLY SELECTED FROM ALL CONSECUTIVE PATIENTS WITH CALCIFIED LESIONS WHO HAD UNDERGONE PCI, AND WHO REQUIRED ADDITIONAL LESION PREPARATION WITH EITHER ROTATIONAL ATHERECTOMY OR SHOCK WAVE INTRAVASCULAR LITHOTRIPSY FOR LM DISEASES (MAIN INCLUSION CRITERIA TO STUDY). PROCEDURAL OUTCOMES (REFERENCE TABLE 3 OF THE PUBLICATION): WITHIN THE PUBLICATION, IT WAS NOTED THAT THE PATIENT EXPIRED DUE TO FATAL IN-STENT THROMBOSIS THAT OCCURRED DURING THE IN-HOSPITAL PERIOD (FIVE DAYS AFTER A PCI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2854762 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death