BEUDAMED
    FDA Adverse Event Death Summary report: Y

    SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 16763601 · Received April 18, 2023

    Report

    Report Number
    3015053858-2023-00020
    Event Type
    Death
    Date Received
    April 18, 2023
    Report Date
    June 6, 2022
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    ALL REPORTS OF DEATHS INITIALLY SUBMITTED ARE BEING SUPPLEMENTED BECAUSE ONE REPORT OF DEATH WAS INADVERTENTLY INCLUDED IN THE SERIOUS INJURY LIST. WE ARE NOW CORRECTING BOTH REPORTS. THE NEW TOTAL REPORT OF DEATHS FOR Q2 IS 127.

    Description of Event or Problem · 0

    SHOCKWAVE MEDICAL, INC. (SWM) HAS APPLIED FOR AND WAS GRANTED THE REQUEST FOR A REGISTRY EXEMPTION, GEN2200325 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 126 DEATHS THAT WERE REPORTED AS PART OF THE CAD POST APPROVAL STUDY REGISTRY FOR THE PERIOD BETWEEN APRIL 1 AND JUNE 30. OTHER PATIENT HARMS ASSOCIATED WITH THESE EVENTS INCLUDE CARDIAC RELATED EVENTS (CARDIAC ARREST, CARDIAC TAMPONADE, MYOCARDIAL INFARCTION, PERFORATION OR RUPTURE) DISSECTION, PULMONARY EDEMA AND STROKE (ISCHEMIC). 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
    625273 SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IV) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVLXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death