BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH THE SHOCKWAVE M5+

    MDR report key: 18116349 · Received November 10, 2023

    Report

    Report Number
    3015053858-2023-00061
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    October 25, 2023
    Report Date
    May 19, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    PPN
    UDI-DI
    00195451000287
    PMA / PMN Number
    K203365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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, NO INVESTIGATION CAN BE PERFORMED. BASED ON THE REPORTED EVENT, THE SHOCKWAVE M5PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER DID NOT MALFUNCTION. THE EMBOLISM WAS NOTED TO HAVE APPEARED AFTER 150 PULSES WERE DELIVERED IN THE RIGHT ILIAC ARTERY. A REVIEW OF THE LOT HISTORY RECORD (LHR) AND TEST DOCUMENTATION DID NOT SHOW ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL SHOCKWAVE MEDICAL, INC. CRITERIA PRIOR TO BEING RELEASED FOR DISTRIBUTION. 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 FEMALE PATIENT IN HER 60'S, UNDERWENT A DISTAL AORTIC TOTAL OCCLUSION PROCEDURE TO TREAT THE RIGHT AND LEFT ILIAC ARTERIES USING THE SHOCKWAVE M5PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER. THE IVL SUCCESSFULLY DELIVERED 150 PULSES IN THE LEFT ILIAC. AFTER THE IVL BALLOON DELIVERED 150 PULSES IN THE RIGHT ILIAC, A DISTAL EMBOLISM WAS OBSERVED. ACCORDING TO THE PHYSICIAN, THE EMBOLISM WAS LOCATED ON TOP OF THE OCCLUSION AND IVL BALLOON WAS UNABLE TO REMOVE THE EMBOLI. THE PATIENT WAS TAKEN TO SURGERY AND UNDERWENT THROMBECTOMY AND ENDOVASCULAR ANEURYSM REPAIR (EVAR). POST SURGERY, THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR A WEEK. THERE WAS NO REPORT OF IVL CATHETER MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243105 SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH THE SHOCKWAVE M5+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER PPN SHOCKWAVE MEDICAL, INC. 8.0X60MM 82257565 00195451000287

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention| O| H