BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 18742152 · Received February 20, 2024

    Report

    Report Number
    3015053858-2024-00012
    Event Type
    Death
    Date Received
    February 20, 2024
    Date of Event
    February 2, 2024
    Report Date
    February 20, 2024
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. THE REPORTED FAILURE OF BALLOON RUPTURE WAS CONFIRMED, AND THE LIKELY CAUSE COULD NOT BE DETERMINED. THE LIKELY CAUSE OF THE PERFORATION, CARDIAC ARREST, AND PATIENT DEATH ALSO COULD NOT BE DETERMINED. THE PHYSICIAN SUGGESTED THE PERFORATION WAS NOT LIKELY CAUSED BY THE BALLOON AT 4 ATMS BUT THAT IT WAS MOST LIKELY DUE TO CALCIUM SHIFT. THE PHYSICIAN SUSPECTS THAT THE PATIENT'S AGE AND MULTIPLE COMORBIDITIES, AS WELL AS HAVING TO USE A COVERED STENT THAT COVERED A DIAGONAL BRANCH ALL CONTRIBUTED TO THE PATIENT'S CARDIAC ARREST AND DEATH. 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 BEING DISTRIBUTED.

    Description of Event or Problem · 0

    A SHOCKWAVE C2 INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE TO TREAT A DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. IT WAS REPORTED THAT THE PATIENT WAS 80 YEARS OLD WITH MULTIPLE COMORBIDITIES. DURING THE PROCEDURE, THE GUIDEWIRE CROSSED THE TREATMENT SITE, AND THE VOLCANO INTRAVASCULAR ULTRASOUND DEVICE WOULD NOT CROSS THE LESION. A 2.0 CORONARY BALLOON WAS USED FOR PRE-DILATION. THE C2 IVL 2.5 CATHETER WAS INSERTED AND SEVEN CYCLES OF PULSES WERE DELIVERED. AFTER DELIVERING THE LAST CYCLE OF PULSES, IT WAS DISCOVERED THAT THE BALLOON RUPTURED. A VESSEL PERFORATION WAS THEN OBSERVED UNDER CONTRAST SO THE PHYSICIAN PLACED A PAPYRUS STENT. AT THE END OF THE PROCEDURE, EVERYTHING LOOKED GOOD WITH THE CALCIFIED LESION FULLY OPEN, AND THE PATIENT DID WELL. TWO DAYS AFTER THE PROCEDURE, THE PATIENT WENT INTO CARDIAC ARREST AND SUBSEQUENTLY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396835 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL2512 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other| R| D