BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO CORONARY IVL CATHETER

    MDR report key: 23350291 · Received October 21, 2025

    Report

    Report Number
    3015053858-2025-00120
    Event Type
    Death
    Date Received
    October 21, 2025
    Date of Event
    October 10, 2025
    Report Date
    October 21, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 THROMBUS, CARDIAC ARREST AND SUBSEQUENT PATIENT DEATH COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. IT WAS REPORTED THAT THE PHYSICIAN DID NOT BELIEVE THE SHOCKWAVE IVL CATHETER TO HAVE BEEN RELATED TO THE ADVERSE EVENTS. SHOCKWAVE MEDICAL SAFETY DETERMINED THAT THROMBOSIS OCCURRED DURING THE PROCEDURE AND IS THEREFORE PROCEDURE RELATED. THE TIMING OF THE EVENT, WHICH OCCURRED AFTER THE USE OF THE CUTTING BALLOON, SUGGESTS THAT IT WAS UNLIKELY RELATED TO THE USE OF IVL AND MORE LIKELY DUE TO THE USE OF THE OTHER DEVICE, THOUGH IT IS POSSIBLE THERE IS A RELATION TO THE USE OF IVL. 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 AERO CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERIES. A TOTAL OF 120 IVL PULSES WERE SUCCESSFULLY DELIVERED. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED A BLOOD CLOT AFTER THE USE OF A CUTTING BALLOON AND SUBSEQUENTLY WENT INTO CARDIAC ARREST. THE PHYSICIAN INSERTED A PENUMBRA CATHETER TO ASPIRATE THE CLOT. THE PATIENT STABILIZED TEMPORARILY; HOWEVER, DURING SHEATH SUTURING, THE PATIENT EXPERIENCED ANOTHER CLOT FORMATION AND ULTIMATELY PASSED AWAY. THE PATIENT'S DEATH OCCURRED AFTER IVL TREATMENT, STENTING AND POST DILATING. IT WAS REPORTED THAT THE PHYSICIAN DID NOT BELIEVE THE SHOCKWAVE IVL CATHETER TO HAVE BEEN RELATED TO THE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841734 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC. C2AIVL3012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Death PENUMBRA CATHETER.| POST-CUTTING BALLOON - UNKNOWN MANUFACTURER.| SHEATH - UNKNOWN MANUFACTURER.