BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER

    MDR report key: 24783751 · Received April 3, 2026

    Report

    Report Number
    3015053858-2026-00035
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 17, 2026
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000027
    PMA / PMN Number
    P200039/S008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED PER ADDITIONAL INFORMATION RECEIVED 30MAR2026: A2: AGE AT THE TIME OF THE EVENT INITIALLY ENTERED AS 20 YEARS OLD SHOULD BE CORRECTED TO "UNKNOWN". A3A: SEX IS MALE. B5: ADDED NEW INFORMATION RECEIVED ON 30MAR2026. B7: ADDED MEDICAL HISTORY. D10: ADDED CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES.

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SHOCKWAVE MEDICAL, INC. THEREFORE, A PHYSICAL EXAMINATION CANNOT BE PERFORMED. PER THE REPORTED INFORMATION, THE DEVICE WAS USED OFF LABEL AS THERE WAS A STENT PRESENT AND THE C2+ DEVICE IS ONLY INDICATED FOR USE IN DE NOVO CORONARY ARTERIES PRIOR TO STENTING. THE PRESENCE OF THE STENT COULD HAVE CONTRIBUTED TO THE BALLOON RUPTURE. HOWEVER, THE BALLOON RUPTURE CANNOT BE CONFIRMED WITHOUT A REVIEW OF THE RETURNED DEVICE. IT WAS REPORTED THAT THE C2+ CORONARY IVL CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERY UNDER AN EXPANDED STENT WHICH IS OFF-LABEL PER THE DEVICE INSTRUCTIONS FOR USE. THE INSTRUCTIONS FOR USE STATE "SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER IS INDICATED FOR LITHOTRIPSY-ENABLED, LOW-PRESSURE BALLOON DILATATION OF SEVERELY CALCIFIED, STENOTIC DE NOVO CORONARY ARTERIES PRIOR TO STENTING." SHOCKWAVE MEDICAL HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION FOR SUBJECT LOT DOES NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL OF SHOCKWAVE MEDICAL, INC. ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

    Description of Event or Problem · 0

    SIXTY PULSES WERE DELIVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY UNDER AN EXPANDED STENT. THE PHYSICIAN WAS AWARE OF THE OFF-LABEL USE AS THE SHOCKWAVE C2+ IVL CATHETER IS INDICATED FOR LITHOTRIPSY-ENABLED, LOW-PRESSURE BALLOON DILATATION OF SEVERELY CALCIFIED, STENOTIC DE NOVO CORONARY ARTERIES PRIOR TO STENTING. DURING THE PROCEDURE, THE BALLOON RUPTURED, WHICH WAS INDICATED BY BLOOD IN THE INFLATOR. FOLLOWING THE BALLOON RUPTURE, THE DISTAL PORTION OF THE BALLOON DEFLATED WHILE THE PROXIMAL PORTION REMAINED INFLATED AND OCCLUSIVE. THERE WAS NO FLOW AROUND THE PROXIMAL END OF THE STENT. THE PHYSICIAN WAS UNABLE TO PULL OUT THE BALLOON BECAUSE THE BALLOON WAS INFLATED. THE PHYSICIAN EVENTUALLY DEFLATED THE BALLOON BY APPLYING NEGATIVE PULLS SEVERAL TIMES AND WAS ABLE TO REMOVE IT WITHOUT PATIENT HARM. A SECOND IVL BALLOON WAS THEN USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THE PHYSICIAN WAS AWARE THE USE OF THE DEVICE WAS OFF-LABEL, ALTHOUGH HE FELT IT WAS NECESSARY BECAUSE OF THE CALCIUM BURDEN BEHIND THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565817 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC. C2PIVL3512 01A251215B 00195451000027

    Patients

    Seq Age Sex Outcome Treatment
    1