BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 14208150 · Received April 26, 2022

    Report

    Report Number
    3015053858-2022-00028
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    April 6, 2022
    Report Date
    April 11, 2022
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. BASED ON THE DESCRIPTION OF THE EVENT, THE IVL DEVICE WAS USED TO TREAT AN IN-STENT RESTENOSIS WHICH IS OUTSIDE THE INDICATIONS FOR USE PER THE DEVICE INSTRUCTIONS FOR USE. THE IVL DEVICE PERFORMED AS INTENDED; THE CAUSE FOR THE ARRYTHMIA EXPERIENCED BY THE PATIENT DURING THE FINAL STAGES OF THE INTERVENTION COULD NOT BE DEFINITIVELY DETERMINED WITH THE INFORMATION AVAILABLE. 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 WHO UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT AN IN-STENT RESTENOSIS DUE TO A CHRONIC UNDER-EXPANDED STENT IN THE RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT AFTER THE FINAL ANGIOGRAPHIC IMAGES WERE TAKEN, THE IVL PROCEDURE WAS ENDED. FOLLOWING THE IVL PROCEDURE, WHILE HOLDING PRESSURE ON THE FEMORAL ACCESS SITE, THE PATIENT EXPERIENCED AN ABNORMAL CARDIAC ARRHYTHMIA AND VITAL SIGNS DETERIORATED. CARDIOPULMONARY RESUSCITATION (CPR) WAS IMMEDIATELY INITIATED, AND AN EMERGENCY PCI WAS STARTED AND A POBA BALLOON WAS USED ON THE PROXIMAL RCA. FOLLOWING THE SECOND PCI PROCEDURE, THE PATIENT WAS REPORTED TO BE STABLE AND DISCHARGED TO HOSPICE THREE DAYS AFTER THE PROCEDURE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774915 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Hospitalization| L| O| R