BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER

    MDR report key: 23652259 · Received November 25, 2025

    Report

    Report Number
    3015053858-2025-00145
    Event Type
    Death
    Date Received
    November 25, 2025
    Date of Event
    November 13, 2025
    Report Date
    November 25, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. THEREFORE, A PHYSICAL EXAMINATION CANNOT BE PERFORMED. THE CAUSE OF THE BACK PAIN, SHORTNESS OF BREATH, AND SUBSEQUENT PATIENT DEATH COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THE PHYSICIAN DOES NOT BELIEVE THE PAIN, SHORTNESS OF BREATH, CARDIAC ARREST, AND SUBSEQUENT PATIENT DEATH IS RELATED TO THE DEVICE. A REVIEW OF THE EVENT BY SHOCKWAVE SAFETY DETERMINED THAT THE REPORTED EVENT WAS POSSIBLY RELATED TO THE DEVICE AND A CASUAL RELATIONSHIP TO THE PROCEDURE. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. THEREFORE, REVIEW OF THE DEVICE MANUFACTURING AND TEST DOCUMENTATION COULD NOT BE COMPLETED. HOWEVER, SHOCKWAVE MEDICAL, INC. HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE TO TREAT A PATIENT'S LEFT ANTERIOR DESCENDING ARTERY (LAD). 80 IVL PULSES WERE DELIVERED SUCCESSFULLY. DURING THE PROCEDURE, THE PATIENT COMPLAINED OF BACK PAIN AND SHORTNESS OF BREATH. WHILE PERFORMING BALLOON ANGIOPLASTY OF THE LAD, THE TEAM PAUSED THE INTERVENTION AND PLACED THE PATIENT IN REVERSE TRENDELENBURG TO HELP THE PATIENT BREATHE. THE PATIENT THEN SUFFERED A CARDIOPULMONARY ARREST; NO FURTHER INTERVENTIONS WERE PERFORMED. OTHER NON-SHOCKWAVE MEDICAL BALLOONS ALONG WITH IVL WERE USED AND A STENT WAS POSITIONED, BUT THE STENT COULD NOT BE ADVANCED ACROSS THE LESION. THE PATIENT PASSED AWAY DURING THE PROCEDURE. THE PHYSICIAN DOES NOT BELIEVE THE PAIN, SHORTNESS OF BREATH, CARDIAC ARREST, AND SUBSEQUENT PATIENT DEATH IS RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920696 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death| O BALLOON - MEDTRONIC.| STENT - MEDTRONIC.