BEUDAMED
    FDA Adverse Event Death Summary report: Y

    SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 16738484 · Received April 13, 2023

    Report

    Report Number
    3015053858-2023-00018
    Event Type
    Death
    Date Received
    April 13, 2023
    Report Date
    February 1, 2022
    Manufacturer
    SHOCKWAVE MEDICAL, INX.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES REFERENCED IN THIS REPORT WERE NOT RETURNED TO SHOCKWAVE MEDICAL, INC. FOR INVESTIGATION THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. SWM IS BLINDED FROM KNOWING THE SITE. DUE TO THIS, INFORMATION ON EVENT DATES, CATHETER LOT NUMBERS, AND DEVICES RETURN ARE NOT AVAILABLE. THE LOT NUMBERS WERE NOT AVAILABLE IN THE REGISTRY CASE REPORT FORMS. 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

    SHOCKWAVE MEDICAL, INC. (SWM) HAS APPLIED FOR AND WAS GRANTED THE REQUEST FOR A REGISTRY EXEMPTION, (B)(4) FOR DATA ACQUIRED FROM THE NATIONAL CARDIOVASCULAR DATA REGISTRY (NCDR) CATHPCI REGISTRY FOR THE SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH THE SHOCKWAVE CORONARY (IVL) CATHETER. THIS REPORT IS TO DOCUMENT A TOTAL OF 87 DEATHS THAT WERE REPORTED AS PART OF THE CAD POST APPROVAL STUDY REGISTRY FOR THE PERIOD BETWEEN JANUARY 1 AND MARCH 31. OTHER PATIENT HARMS ASSOCIATED WITH THESE EVENTS INCLUDE CARDIAC RELATED EVENTS (CARDIAC ARREST, CARDIAC TAMPONADE, MYOCARDIAL INFARCTION, CARDIOGENIC SHOCK), PERFORATION, AND PULMONARY EDEMA. SWM IS BLINDED FROM KNOWING THE SITE. DUE TO THIS, INFORMATION ON EVENT DATES, CATHETER LOT NUMBERS, AND DEVICES RETURN ARE NOT AVAILABLE. THE LOT NUMBERS WERE NOT AVAILABLE IN THE REGISTRY CASE REPORT FORMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480324 SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSU (VL) CATHETER QMG SHOCKWAVE MEDICAL, INX. C2IVLXXXX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death