BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 13980535 · Received April 1, 2022

    Report

    Report Number
    3015053858-2022-00019
    Event Type
    Death
    Date Received
    April 1, 2022
    Date of Event
    March 14, 2022
    Report Date
    March 15, 2022
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS EVENT WAS NOT RETURNED TO SHOCKWAVE FOR INVESTIGATION THEREFORE, NO DEVICE INVESTIGATION COULD BE PERFORMED. THE PHYSICIAN STATED THAT IT WASN'T THE IVL THERAPY THAT CONTRIBUTED TO THE ADVERSE EVENT BUT THE PROCESS OF INFLATING THE BALLOON. THE PHYSICIAN ALSO STATED THAT ANY BALLOON ANGIOPLASTY DEVICE COULD HAVE CAUSED THE SAME COMPLICATION AND SUBSEQUENT PATIENT DEATH. 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

    A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON WAS USED IN A PATIENT EXPERIENCING ANGINA UNDERWENT A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT A DE NOVO LESION AT THE LEFT MAIN (LM) AND LEFT ANTERIOR DESCENDING (LAD) ARTERIES. ACCESS WAS OBTAINED VIA RIGHT RADIAL APPROACH. DURING THE PROCEDURE, THE IVL BALLOON DELIVERED 10 PULSES WHEN THE PATIENT SHOWED SIGNS OF DISTRESS. THE PATIENT WAS IMMEDIATELY PLACED ON A BALLOON PUMP BECAUSE OF LOW EJECTION FRACTION (EF) AND WAS ALSO GIVEN LOPRESSOR (BETA BLOCKER). AFTER THE PATIENT BECAME STABLE, THE PHYSICIAN TREATED THE LM WITH THE IVL BALLOON BUT AFTER THE 13TH PULSE, THE BALLOON PUMP WAS NOTED TO HAVE FAILED. THE PATIENT EXPIRED ON THE TABLE AFTER ATTEMPTS TO REGAIN PERFUSION HAD FAILED. REPORTEDLY, THE PHYSICIAN SAID IT WASN'T THE IVL THERAPY THAT CONTRIBUTED BUT THE PROCESS OF INFLATING THE BALLOON IN THE LEFT MAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727333 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL4012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death