BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 12986674 · Received December 13, 2021

    Report

    Report Number
    3015053858-2021-00029
    Event Type
    Death
    Date Received
    December 13, 2021
    Date of Event
    November 16, 2021
    Report Date
    November 16, 2021
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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, THE LIKELY CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE PROVIDED INFORMATION, THE MID LAD VESSEL PERFORATION WAS NOTED AFTER THE TARGET VESSEL WAS POST-DILATED WITH A 3.0MM NC BALLOON (NON-SHOCKWAVE DEVICE) FOLLOWED BY A 2.75MM DRUG ELUTING STENT (DES) PLACEMENT. BASED ON THIS INFORMATION, SHOCKWAVE MEDICAL IS OF THE OPINION THAT THE ADVERSE EVENT IS NOT RELATED TO THE IVL SYSTEM. SHOCKWAVE MEDICAL 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 CORONARY LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT AN (B)(6) YEAR OLD MALE PATIENT USING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE AT THE LEFT MAIN/CIRCUMFLEX (CFX) AND MID AND PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) SUPPORTED BY AN IMPELLA DEVICE. A 2.5MM NON-COMPLIANT (NC) BALLOON WAS USED TO PRE-DILATE THE MID LAD. IVUS IMAGING WAS UTILIZED. A 3.0MM IVL BALLOON CATHETER WAS INTRODUCED INTO THE TARGET VESSEL, AND WAS ABLE TO SUCCESSFULLY DELIVER A TOTAL OF 60 PULSES, 2 CYCLES, IN THE MID LAD, AND THE REMAINING PULSES WERE DELIVERED IN THE PROXIMAL LAD AND LEFT MAIN. THE VESSEL WAS POST-DILATED WITH A 3.0MM NC BALLOON, FOLLOWED BY THE PLACEMENT OF A 2.75MM DRUG ELUTING STENT (DES). THE DES WAS POST DILATED WITH THE 3.0MM NC BALLOON, AT WHICH TIME THE PATIENT EXPERIENCED A PERFORATION OF THE MID LAD VESSEL. THREE (3) COVERED STENTS WERE IMPLANTED AT THE LOCATION OF THE PERFORATION, AND MULTIPLE NC BALLOONS WERE USED TO TAMPONADE THE BLEEDING. A PERICARDIOCENTESIS PROCEDURE WAS PERFORMED TO REMOVE FLUID THAT HAS BUILT UP IN THE SAC AROUND THE PERICARDIUM. THE PATIENT WAS ABLE TO BE STABILIZED FOLLOWING THE PROCEDURE AND WAS TRANSFERRED TO THE RECOVERY ROOM WHERE HE EVENTUALLY EXPIRED ON THE SAME DAY. IT WAS NOTED THAT THE IVL PORTION OF THE PROCEDURE WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886946 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Death DRUG-ELUTING STENT (DES) - UNKNOWN MANUFACTURER| NON-COMPLIANT (NC) BALLOON - UNKNOWN MANUFACTURER