BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 17631989 · Received August 28, 2023

    Report

    Report Number
    3015053858-2023-00050
    Event Type
    Death
    Date Received
    August 28, 2023
    Date of Event
    August 11, 2023
    Report Date
    August 18, 2023
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000102
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER FDA'S REQUEST, SHOCKWAVE MEDICAL, INC. HAS CORRECTED THE PRODUCT CODE FROM OMG TO QMG.

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SHOCKWAVE MEDICAL, INC. THEREFORE, NO INVESTIGATION CAN BE PERFORMED. BASED ON THE COMPLAINT DESCRIPTION, THE PATIENT EXPERIENCED LOST CONDUCTION FROM A LEFT BUNDLE BRANCH BLOCK (LBBB) DURING THE IVL TREATMENT. A TEMPORARY PACEMAKER WAS INSERTED HOWEVER, THE PATIENT EXPIRED SEVERAL DAYS LATER. 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) OF THE LEFT ANTERIOR DESCENDING (LAD) AND CIRCUMFLEX (CX) ARTERIES AND THE LEFT MAIN (LM) DUE TO HEAVY CALCIUM AS DETERMINED BY OPTICAL COHERENCE TOMOGRAPHY (OCT) AND POST ORBITAL ATHERECTOMY. ARTERIAL ACCESS TO THE TARGET LESION WAS OBTAINED VIA THE FEMORAL ARTERY. ORBITAL ATHERECTOMY WAS PERFORMED ALONG WITH HIGH PRESSURE BALLOON INFLATIONS AND THE PATIENT'S RHYTHM CHANGED AFTER SEVERAL INFLATIONS AND PULSE CYCLES WITH THE SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON. REPORTEDLY, DURING THE IVL TREATMENT, THE PATIENT LOST CONDUCTION FROM A LEFT BUNDLE BRANCH BLOCK (LBBB) THAT DISRUPTED THE ELECTRICAL IMPULSE TO CAUSE THE HEART TO BEAT. A TEMPORARY PACEMAKER WAS INSERTED, AND THE PROCEDURE CONTINUED AS PLANNED. IT TOOK ONLY A FEW MINUTES TO INSERT THE PACEMAKER AFTER THE CONDUCTION WAS LOST. THE PACEMAKER WAS NOT REMOVED AFTER THE PCI AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). IT WAS REPORTED THAT SEVERAL DAYS AFTER THE PROCEDURE, THE PATIENT EXPIRED OF UNRELATED COMPLICATIONS. THE PHYSICIAN WAS ADAMANT THAT IVL WAS NOT THE CAUSE OF THE PATIENT'S LOSS OF CONDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086209 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3512 A230201F 00195451000102
    329293 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3512 A230201F 00195451000102

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death HIGH PRESSURE BALLOONS - UNKNOWN BRAND/ MNFR.| OPTICAL COHERENCE TOMOGRAPHY - UNKNOWN MFR.| PACEMAKER - UNKNOWN BRAND/ MANUFACTURER.