BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 11850412 · Received May 19, 2021

    Report

    Report Number
    3015053858-2021-00007
    Event Type
    Death
    Date Received
    May 19, 2021
    Date of Event
    February 26, 2021
    Report Date
    July 2, 2021
    Manufacturer
    SHOCKWAVE MEDICAL, INC
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO SHOCKWAVE AND THE EVALUATION WAS COMPLETED. BASED ON THE INVESTIGATION OBSERVATIONS, THE REPORTED BALLOON RUPTURE WAS CONFIRMED AND DETERMINED TO POSSIBLY BE ATTRIBUTED TO PATIENT CALCIUM WITHIN THE VESSEL THAT CAUSED DAMAGE TO THE BALLOON SURFACE, WHICH IS A KNOWN INHERENT RISK OF THE DEVICE. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION DOES NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL OF SWMI'S ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL BE RETURNED TO SHOCKWAVE FOR EVALUATION THEREFORE, THE DEVICE EVALUATION IS ANTICIPATED AND HAS NOT YET BEGUN. SHOCKWAVE MEDICAL HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION DOES NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL OF SWMI'S ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

    Description of Event or Problem · 1

    A SHOCKWAVE C2 SHOCKWAVE 2.5X12MM IVL CATHETER WAS USED TO TREAT A CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS FIRST PREDILATED USING A NON-COMPLIANT BALLOON (NON-SHOCKWAVE BALLOON), WHICH WAS FOLLOWED UP WITH ADDITIONAL PRE-DILATION OF THE LESION USING A OPN NON-COMPLIANT ULTRA HIGH-PRESSURE BALLOON (NON-SHOCKWAVE BALLOON). AS THE LESION DID NOT YIELD, A C2 SHOCKWAVE 2.5X12MM IVL CATHETER WAS USED TO PRE-DILATE THE VESSEL IN WHICH AFTER 2 CYCLES THE BALLOON BURST. IMMEDIATELY FOLLOWING THE BALLOON BURST, A DISSECTION OF THE VESSEL AND ABRUPT VESSEL CLOSURE WAS OBSERVED. IT WAS REPORTED THAT THE NC BALLOONS (NON-SHOCKWAVE) FUNCTIONED AS INTENDED. THERE WAS NO INDICATION OF THE DISSECTION FOLLOWING THE USE OF THE NC BALLOON AND OPN NC ULTRA HIGH-PRESSURE BALLOON, PRIOR TO THE SHOCKWAVE DEVICE THERAPY. IN ADDITION, THE DISSECTION GRADE COULD NOT BE DETERMINED AT THE TIME; THERE WERE NO ATTEMPTS TO TREAT THE DISSECTION DUE TO IMMEDIATE THROMBUS FORMATION, AND THE PATIENT WENT INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS REQUIRED IMMEDIATELY FOLLOWING THE DISSECTION AND ABRUPT ARTERY CLOSURE. THE CPR WAS REPORTED TO BE SUCCESSFUL FOR A WHILE; HOWEVER, THE PATIENT CONDITION WORSENED, AND THE PATIENT WAS PUT ON VENTILATOR SUPPORT. THE PATIENT EXPIRED 1-DAY POST-OP. THE CAUSE OF DEATH WAS REPORTED AS SUDDEN CARDIAC ARREST/ASYSTOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744009 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC C2IVL2512 P200818H

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| O NC BALLOON (UNKNOWN MANUFACTURER)| OPN NC ULTRA HIGH-PRESSURE (UNKNOWN MANUFACTURER)| NC BALLOON (UNKNOWN MANUFACTURER)| OPN NC ULTRA HIGH-PRESSURE (UNKNOWN MANUFACTURER)