BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 17278223 · Received July 7, 2023

    Report

    Report Number
    3015053858-2023-00040
    Event Type
    Death
    Date Received
    July 7, 2023
    Date of Event
    June 19, 2023
    Report Date
    June 19, 2023
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. THE REPORTED DEVICE FAILURE WAS CONFIRMED. THE CAUSE OF THE IVL CATHETER BUCKLING AND PROLAPSING IN HALF THAT CAUSED A FLOW LIMITING DISSECTION CAN BE ATTRIBUTED TO USER ERROR. IT WAS REPORTED THAT THE PHYSICIAN REINSERTED THE DEVICE AFTER IT WAS WITHDRAWN FROM THE PATIENT'S ANATOMY. PER THE INSTRUCTIONS FOR USE (IFU), "CAUTION: IVL CATHETER ONCE PULLED OUT OF THE BODY SHOULD NOT BE REINSERTED FOR ADDITIONAL INFLATION OR LITHOTRIPSY TREATMENTS. BALLOON CAN BE DAMAGED IN THE PROCESS." 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

    IT WAS REPORTED THAT A 61-YEAR-OLD PATIENT WHO HAD AN END-STAGE RENAL DISEASE (ESRD) UNDERWENT AN ILV PROCEDURE TO TREAT A CONCENTRIC DE NOVO LESION IN THE MID DISTAL CIRCUMFLEX (CX) ARTERY. PRIOR TO THE PROCEDURE, THE LESION WAS PRE-DILATED WITH A EUPHORA SEMI-COMPLIANT CORONARY BALLOON CATHETER. THEN THE PHYSICIAN ADVANCED TWO GUIDEWIRES INTO THE CX FOLLOWED BY A SHOCKWAVE C2 CORONARY LITHOTRIPSY (IVL) CATHETER. THE IVL SUCCESSFULLY DELIVERED 60 PULSES TO THE TARGET LESION, AND IT WAS POST DILATED WITH STENT IMPLANTATION. THE IVL WAS REMOVED FROM THE BODY AND THEN REINSERTED IN AN ATTEMPT TO TREAT THE CX. THEN THE IVL CATHETER WAS ADVANCED IN AN ACUTE ANGLE TO TRANSITION INTO THE CX FROM THE LEFT MAIN CORONARY ARTERY (LMCA). THE IVL BALLOON BUCKLED AND PROLAPSED IN HALF INTO THE LEFT ANTERIOR DESCENDING ARTERY (LAD) CAUSING A FLOW-LIMITING DISSECTION IN THE ORIGIN OF THE CX AND THERE WAS NO FLOW INTO THE LAD. THE DISSECTION COULD NOT BE TREATED DUE TO THE INABILITY TO GET A WIRE ACROSS SO A TEMPORARY PACEMAKER WAS PLACED TO STABILIZE THE SINUS RHYTHM. THE PATIENT WAS NOT A CANDIDATE FOR CORONARY ARTERY BYPASS GRAFTING (CABG). THE PATIENT'S CONDITION RAPIDLY DECLINED AND SIMULTANEOUSLY EXPERIENCED CARDIAC ARREST. THE PATIENT WAS PROVIDED CARDIOPULMONARY RESUSCITATION (CPR) AND WAS INTUBATED TO PROVIDE CARDIOVERSION TREATMENT TO RESTORE A NORMAL HEARTBEAT. ALL INTERVENTIONS PERFORMED WERE UNSUCCESSFUL AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030967 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3012 A221117M

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Death EUPHORA SEMI-COMPLIANT CORONARY BALLOON CATHETER .| PACEMAKER -UNKNOWN BRAND/MANUFACTURER.