BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER

    MDR report key: 24989379 · Received April 24, 2026

    Report

    Report Number
    3015053858-2026-00039
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 24, 2026
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039/S008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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. 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 UNDERSIZED STENT WHICH IS OFF-LABEL PER THE DEVICE INSTRUCTIONS FOR USE (IFU). THE IFU 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. PER THE REPORTED INFORMATION, THE BALLOON RUPTURE OCCURRED WHEN AT A PRESSURE OF 6 ATM. PER THE IFU, THIS IS CONSIDERED OFF-LABEL USE. IFU STATES, "4 ATM IS LITHOTRIPSY TREATMENT BALLOON PRESSURE. 6 ATM IS NOMINAL BALLOON PRESSURE AND POST-TREATMENT ANGIOPLASTY PRESSURE. 10 ATM IS RBP (RATED BURST PRESSURE) OF THE BALLOON". 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 CORONARY ARTERY. THE DEVICE WAS PREPPED SUCCESSFULLY AND 40 PULSES WERE DELIVERED. THE SHOCKWAVE PROCEDURE WAS SUCCESSFULLY COMPLETED. . IVL WAS USED DURING AN INTERVENTION TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) FOLLOWING AN UNDERSIZED STENT PLACEMENT. A 4.0MM NON-COMPLAINT (NC) BALLOON WAS USED, FOLLOWED BY A 3.5MM SHOCKWAVE IVL BALLOON AT 6 ATM AND SUBSEQUENTLY INCREASED TO 8 ATM, OUTSIDE THE RECOMMENDED BALLOON PRESSURE FOR THE IVL BALLOON PER THE DEVICE IFU. FOUR IVL TREATMENT CYCLES WERE COMPLETED FOLLOWING STENT PLACEMENT, AND DURING THE FIFTH CYCLE, THE IVL BALLOON RUPTURED POTENTIALLY CAUSING PERFORATION IN THE LAD AND DISSECTION EXTENDING INTO THE LEFT MAIN (LM) CORONARY ARTERY. THE PATIENT REQUIRED PERICARDIOCENTESIS FOR BLEEDING INTO THE PERICARDIAL SPACE AND PLACEMENT OF AN ALTERNATE COVERED STENT TO TREAT THE PERFORATION OF THE LAD, PLUS ADDITIONAL STENT PLACEMENT TO TREAT THE DISSECTION IN THE LM. THE PHYSICIAN BELIEVES THE PATIENT REQUIRED PERICARDIOCENTESIS BECAUSE A PERFORATION OF THE LAD CORONARY ARTERY CAUSED BLEEDING INTO THE PERICARDIAL SPACE. THE PHYSICIAN ALSO NOTES THE SHOCKWAVE DEVICE MAY HAVE CONTRIBUTED WHEN A PINHOLE RUPTURE IN THE BALLOON OCCURRED IN THE PRESENCE OF AN UNDER EXPANDED STENT IN CONJUNCTION OF EXCESSIVE IVL BALLOON PRESSURE, POTENTIALLY CAUSING THE PERFORATION. THE PATIENT ULTIMATELY RECOVERED AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445440 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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| O INTRAVASCULAR ULTRASOUND (IVUS) CATHETER - UNK MFG| PTA BALLOONS - UNK MFG