BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER

    MDR report key: 23537570 · Received November 12, 2025

    Report

    Report Number
    3015053858-2025-00133
    Event Type
    Death
    Date Received
    November 12, 2025
    Report Date
    November 12, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039/S008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 INABILITY TO CROSS THE LESION, DETACHMENT COMPONENT OF THE CATHETER SHAFT, AND SUBSEQUENT MYOCARDIAL INFARCTION, CORONARY OBSTRUCTION/OCCLUSION, AND DEATH COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. 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 MEDWATCH REPORT MW5177860 REGARDING A SHOCKWAVE C2+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A TARGET LESION IN THE CORONARY ARTERY. DURING THE PROCEDURE, THE IVL CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. SUBSEQUENTLY, A 3.0 MM EMERGE BALLOON CATHETER WAS ADVANCED AND INFLATED WITH MINIMAL WASTE. A 3.50 X 48 MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS USED BUT ALSO FAILED TO CROSS THE LESION. DURING REMOVAL OF THE DES SYSTEM, A STENT STRUT BECAME DETACHED FROM THE DISTAL END OF THE CATHETER, AND AFTER APPLYING TRACTION, THE SHAFT FRACTURED. A SNARE WAS EMPLOYED BUT UNSUCCESSFUL IN RESOLVING THE DEVICE ISSUE. IT WAS ALSO REPORTED THAT THE PATIENT HAD EXPERIENCED CORONARY OBSTRUCTION/OCCLUSION AND A MYOCARDIAL INFARCTION. THE PATIENT SUBSEQUENTLY UNDERWENT CORONARY ARTERY BYPASS GRAFTING (CABG). HOWEVER, THE PATIENT DIED. DATE OF EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2594002 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R| O EMERGE BALLOON CATHETER.| SYNERGY XD DRUG-ELUTING STENT.