BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER

    MDR report key: 25192261 · Received May 15, 2026

    Report

    Report Number
    3015053858-2026-00046
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    February 27, 2026
    Report Date
    May 15, 2026
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT IS NOT EXPECTED TO BE RETURNED TO SHOCKWAVE MEDICAL, INC. THEREFORE, A PHYSICAL EXAMINATION CANNOT BE PERFORMED. THE CAUSE OF THE FLOW LIMITING DISSECTION, OCCLUSION, AND SUBSEQUENT MYOCARDIAL INFARCTION AND REVASCULARIZATION COULD NOT BE DEFINITIVELY DETERMINED. THE PHYSICIAN REPORTED THAT THE MI AND REVASCULARIZATION MAY HAVE BEEN RELATED TO THE IVL CATHETER. THERE WAS NO REPORT OF A DEVICE MALFUNCTION RELATED TO THE IVL CATHETER, AND THERE IS INSUFFICIENT INFORMATION TO ASSESS THE RELATIONSHIP TO THE IVL CATHETER. 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

    THIS EVENT WAS REPORTED TO SHOCKWAVE VIA A NON-SHOCKWAVE SPONSORED JAPAN POST-MARKET CLINICAL STUDY (MARBLE J), A PROSPECTIVE, MULTICENTER STUDY EVALUATING THE SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY SYSTEM IN CALCIFIED CORONARY ARTERY LESIONS. A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE, AND THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI) AND REVASCULARIZATION. THE REPORTED INFORMATION DID NOT SPECIFY WHETHER THE EVENT OCCURRED BEFORE, DURING, OR FOLLOWING THE IVL PROCEDURE. DURING THE PROCEDURE, 30 IVL PULSES WERE DELIVERED TO THE LEFT ANTERIOR DESCENDING ARTERY (LAD #6) AND AN OCCLUSION WAS CONFIRMED. BALLOON DILATION WITH A RYUSEI BALLOON FOR FIVE MINUTES TEMPORARILY IMPROVED FLOW. OPTICAL COHERENCE TOMOGRAPHY (OCT) REVEALED A REFLUX DISSECTION, AND A NAGOMI STENT WAS PLACED. THEREAFTER, THE FIRST DIAGONAL BRANCH OF THE LAD (D1) BECAME OCCLUDED; BALLOON DILATION OF D1 FAILED TO RESTORE FLOW. THE OCCLUSION WAS ATTRIBUTED TO A DISSECTION, AND THE PROCEDURE WAS TERMINATED. THE PATIENT WAS DISCHARGED AND HAD OUTPATIENT FOLLOW-UPS ON (B)(6) 2026 WITH NO PARTICULAR PROBLEMS. THE PHYSICIAN BELIEVES THE SHOCKWAVE IVL DEVICE CONTRIBUTED TO THE PATIENT'S MI AND REVASCULARIZATION. HOWEVER, THERE WAS NO REPORT OF A DEVICE MALFUNCTION RELATED TO THE IVL CATHETER, AND THERE IS INSUFFICIENT INFORMATION TO ASSESS THE RELATIONSHIP TO THE IVL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243829 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL2512 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1