BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER

    MDR report key: 18223024 · Received November 28, 2023

    Report

    Report Number
    3015053858-2023-00070
    Event Type
    Death
    Date Received
    November 28, 2023
    Date of Event
    November 9, 2023
    Report Date
    May 19, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000102
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. FOR INVESTIGATION THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. BASED ON THE REPORTED INFORMATION, THE IVL CATHETER WAS UNABLE TO CROSS THE LESION AND IT WAS NOTED THAT A PERFORATION OCCURRED FROM PROXIMAL TO LESION SITE. IT IS UNKNOWN IF THE PERFORATION WAS TREATED BUT IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO SURGERY AND SUBSEQUENTLY EXPIRED. A REVIEW OF THE LOT HISTORY RECORD (LHR) AND TEST DOCUMENTATION DID NOT SHOW ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL SHOCKWAVE MEDICAL, INC. CRITERIA PRIOR TO BEING RELEASED FOR DISTRIBUTION. SHOCKWAVE MEDICAL, INC. HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT A CONCENTRIC DE NOVO LESION LOCATED IN THE LEFT CIRCUMFLEX (LCX) ARTERY USING A SHOCKWAVE C2 PLUS CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER. PRIOR TO THE PROCEDURE, THE TARGET LESION WAS PRE-DILATED WITH A NON-COMPLIANT (NC) BALLOON. WHEN THE IVL WAS ADVANCED TOWARDS THE TARGET LESION, IT WAS UNABLE TO CROSS SO A STENT WAS PLACED IN THE LCX AND POST DILATED WITH A 3.5MM NON-COMPLIANT (NC) BALLOON. THE PHYSICIAN WANTED MORE EXPANSION SO A 4.0MM NC BALLOON WAS USED AND IMMEDIATELY, A PERFORATION WAS OBSERVED PROXIMAL TO THE LESION. THE NC BALLOON WAS USED TO TAMPONADE THE VESSEL HOWEVER, IT WAS UNSUCCESSFUL. THE PHYSICIAN ATTEMPTED TO USE A COVERED STENT BUT COULDN'T GO IN DUE TO THE STENT AND SEVERE ANGULATION. THE PATIENT WAS TRANSFERRED TO SURGERY IN AN ATTEMPT TO REPAIR THE AORTIC VALVE HOWEVER, THE PATIENT EXPIRED. THE PHYSICIAN BELIEVES THAT THE CAUSE OF THE PATIENT'S DEATH WAS NOT DUE TO THE IVL. IT WAS DUE TO THE PATIENT'S ANATOMY AND VESSEL CALCIFICATION ALONG WITH THE COMPLICATIONS DURING SURGICAL VALVE REPAIR THAT ULTIMATELY CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601152 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. 3.5 X 12MM 13A230718A 00195451000102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death