BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 12913137 · Received December 1, 2021

    Report

    Report Number
    3015053858-2021-00025
    Event Type
    Death
    Date Received
    December 1, 2021
    Date of Event
    November 3, 2021
    Report Date
    November 4, 2021
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000102
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. VISUAL INSPECTION DID NOT SHOW ANY TEARS OR PINHOLES ON THE BALLOON. THE EMITTERS SHOWED SIGNS OF WEAR, AN INDICATION THAT THEY HAVE BEEN FIRED. THE OPERATING PHYSICIAN INDICATED THAT THE IVL THERAPY PERFORMED AS INTENDED AND WAS NOT AT FAULT. THE PERFORATION OCCURRED DURING POST DILATION OF THE STENT (NON-SHOCKWAVE PRODUCT) USING A NON-COMPLIANT (NC) BALLOON (NON-SHOCKWAVE PRODUCT). BASED ON THIS INFORMATION, SHOCKWAVE MEDICAL IS OF THE OPINION THAT THE ADVERSE EVENT IS NOT RELATED TO THE IVL SYSTEM. BASED ON THE INVESTIGATION OF THE DEVICE, THE REPORTED EVENT OF DEVICE MALFUNCTION COULD NOT BE CONFIRMED. SHOCKWAVE MEDICAL, INC. HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED. 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.

    Description of Event or Problem · 0

    A SHOCKWAVE C2 INTRAVASCULAR LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT A HEAVILY CALCIFIED DE NOVO LESION AT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN PRE-DILATED THE LESION WITH TWO DIFFERENT SIZED BALLOONS AND THEN ACTIVATED THE IVL BALLOON CATHETER. IT SUCCESSFULLY DELIVERED 40 PULSES AT 4 ATMOSPHERES FOLLOWED BY A SUCCESSFUL PROMUS DRUG-ELUTING STENT (DES) PLACEMENT. AFTER POST DILATATION OF THE STENT USING A 3.5 MM NON-COMPLIANT (NC) BALLOON, THE PHYSICIAN REALIZED THERE WAS AN ARTERIAL PERFORATION. IT WAS REPORTED THAT THE PATIENT REFUSED TO UNDERGO A CORONARY ARTERY BYPASS GRAFT (CABG). THE PATIENT OPTED FOR AN ENDOVASCULAR APPROACH. THE PHYSICIAN INSERTED A BALLOON CATHETER TO TAMPONADE THE BLEEDING FOLLOWED BY A COVERED STENT PLACEMENT. AT THIS TIME, CARDIOPULMONARY RESUSCITATION (CPR) BEGAN, BUT THE PATIENT DID NOT MAKE IT AND EXPIRED ON THE TABLE. THE PHYSICIAN BELIEVES THAT THE IVL BALLOON CATHETER PERFORMED WELL, AND IT DID NOT CONTRIBUTE TO THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810247 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER NTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3512 A210318K 00195451000102

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death NON-COMPLIANT (NC) BALLOON - UNKNOWN MANUFACTURER| SYNERGY STENT - BOSTON SCIENTIFIC