BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 18608725 · Received January 30, 2024

    Report

    Report Number
    3015053858-2024-00003
    Event Type
    Injury
    Date Received
    January 30, 2024
    Date of Event
    January 5, 2024
    Report Date
    January 5, 2024
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000096
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO SHOCKWAVE MEDICAL, INC. FOR INVESTIGATION AND A PHYSICAL EXAMINATION WAS PERFORMED. THE REPORTED INABILITY TO REMOVE THE DEVICE WAS UNABLE TO BE CONFIRMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE REPORTED DETACHED CATHETER COMPONENT WAS CONFIRMED. ONLY THE PROXIMAL PORTION OF THE DEVICE WAS RETURNED SO THE EXACT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DEFINITIVELY DETERMINED. PER THE REPORTED INFORMATION, IT WAS NOTED THAT THE DEVICE WAS USED FOR TREATMENT WITHIN A STENT. PER THE IFU, THE DEVICE IS INDICATED FOR USE IN "DE NOVO CORONARY ARTERIES PRIOR TO STENTING." THE PRESENCE OF THE STENT COULD HAVE CONTRIBUTED TO THE TO THE INABILITY TO REMOVE THE DEVICE. A REVIEW OF THE LOT HISTORY RECORDS (LHRS) AND TEST DOCUMENTATION DID NOT SHOW ANY ISSUES WITH THE MANUFACTURING OF THE DEVICES. THE DEVICES 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

    A C2 CORONARY IVL CATHETER WAS USED TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ACCESS TO THE TARGET LESION WAS OBTAINED VIA THE RADIAL ARTERY. THE IVL BALLOON DELIVERED 30 PULSES INSIDE A PRE-EXISTING STENT. UPON REMOVAL OF THE IVL CATHETER, IT BECAME STUCK IN THE VESSEL. THE IVL CATHETER BECAME DETACHED AND THE PHYSICIAN ENCOUNTERED DIFFICULTIES IN REMOVING THE DETACHED COMPONENT. THE PHYSICIAN INSERTED AN IMPELLA VENTRICULAR ASSIST DEVICE. HOWEVER, THE PATIENT'S CARDIAC OUTPUT DECREASED. DURING THIS TIME, THE PATIENT STARTED EXHIBITING SYMPTOMS THAT REQUIRED BEING TRANSFERRED TO THE OPERATING ROOM (OR). THE PATIENT UNDERWENT THORACOTOMY TO RETRIEVE THE DETACHED PORTION OF THE IVL CATHETER AND A CORONARY ARTERY BYPASS GRAFT (CABG) WAS ALSO PERFORMED. IT WAS ALSO REPORTED THAT THE LAD WAS DISSECTED DUE TO THE MANIPULATION OF THE CATHETER TO REMOVE IT. THE PATIENT IS REPORTED TO BE RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250205 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3012 RRB230330G 00195451000096

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R| H| L IMPELLA VENTRICULAR ASSIST DEVICE - UNKNOWN MFR