BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 16947373 · Received May 17, 2023

    Report

    Report Number
    3015053858-2023-00030
    Event Type
    Injury
    Date Received
    May 17, 2023
    Date of Event
    May 10, 2023
    Report Date
    May 10, 2023
    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 REPORT WAS NOT RETURNED TO SHOCKWAVE MEDICAL, INC. FOR INVESTIGATION THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. BASED ON THE REPORTED EVENT, THE PATIENT EXPERIENCED DISSECTION OF THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY FOLLOWING A HIGH PRESSURIZATION OF A NON-COMPLIANT (NC) BALLOON. THE CAUSE OF THE DISSECTION COULD NOT BE DEFINITIVELY DETERMINED. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE ACCESS SITE WAS OBTAINED VIA RADIAL ARTERY. PRIOR TO THE PROCEDURE, THE LESION WAS PRE-DILATED WITH A NON-COMPLIANT (NC) BALLOON. DUE TO A NOTABLE CALCIUM, THE LESION COULD NOT BE EXPANDED WITH THE NC BALLOON, SO THE PHYSICIAN USED A C2 IVL CATHETER. THE IVL TREATMENT WAS SUCCESSFULLY COMPLETED. FOLLOWING THE TREATMENT, THE LESION WAS POST DILATED WITH AN NC BALLOON AT HIGH ATMS. THAT'S WHEN THE DISSECTION WAS NOTED AT THE PROXIMAL LAD. SINCE THE LESION COULD NOT BE TREATED WITH COVERED STENT BECAUSE IT WAS UNABLE TO BE EXPANDED, THE PATIENT WAS TRANSFERRED FROM THE TABLE TO THE OPERATING ROOM (OR) FOR A BYPASS SURGERY. THE PATIENT STAYED LONGER IN THE HOSPITAL AND IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603499 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL2512 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| H| O| R NON-COMPLIANT (NC) CATHETER