BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 12081394 · Received June 28, 2021

    Report

    Report Number
    3015053858-2021-00010
    Event Type
    Death
    Date Received
    June 28, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 14, 2021
    Manufacturer
    SHOCKWAVE MEDICAL, INC
    Product Code
    QMG
    UDI-DI
    00195451000102
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THE REPORTED CARDIAC ARREST 30 MINUTES POST-OP COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE. THERE WAS NO DEVICE ISSUE/ MALFUNCTION REPORTED AND WAS REPORTED TO HAVE FUNCTIONED AS INTENDED. THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION AS DEVICE CAUSALITY CANNOT BE RULED OUT WITH THE INFORMATION AVAILABLE. BASED ON THE INFORMATION REPORTED VIA A SITE FILED VIGILANCE REPORT TO THE COMPETENT AUTHORITY, THE PATIENT HAD HEAVILY CALCIFIED CORONARY ARTERY DISEASE WHICH WAS UNRESPONSIVE TO THE USE OF SEMI-COMPLIANT AND NON-COMPLAINT BALLOON CATHETERS. THE SHOCKWAVE DEVICE FUNCTIONED AS INTENDED, ADEQUATELY RESOLVING THE CORONARY STENOSIS FOLLOWED BY STENT IMPLANTATION, GAINING THE EFFECTIVE REFERENCE VESSEL LUMEN. THERE WERE NO CLINICAL OR ANGIOGRAPHIC EVENTS DETECTED DURING THE ENTIRE SHOCKWAVE PROCEDURE. THE DEVICE MENTIONED IN THE COMPLAINT WAS DISCARDED AND IS NOT AVAILABLE FOR INVESTIGATION, HENCE A PHYSICAL INSPECTION OF THE DEVICE WAS NOT POSSIBLE. HOWEVER, THERE IS NO INDICATION OF A DEVICE MALFUNCTION REPORTED FROM THE SITE, AND THERE WERE NO CLINICAL OR ANGIOGRAPHIC EVENTS DETECTED DURING THE ENTIRE SHOCKWAVE PROCEDURE. FURTHERMORE, SHOCKWAVE MEDICAL (SWMI) 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 CORONARY LITHOTRIPSY (IVL) DEVICE WAS SUCCESSFULLY USED TO TREAT A PATIENT WITH HEAVY, RESISTANT CALCIUM IN THE CORONARY. IT WAS NOTED THAT A SEMI-COMPLIANT BALLOON DID NOT WORK, AND IVL WAS USED WITH GOOD ACUTE RESULTS. THE SHOCKWAVE DEVICE WAS REPORTED TO ADEQUATELY RESOLVE THE CORONARY STENOSIS FOLLOWING IVL TREATMENT AND STENT IMPLANTATION, GAINING THE EFFECTIVE REFERENCE VESSEL LUMEN. THE PHYSICIAN USED A CUTTING BALLOON PRIOR TO THE SHOCKWAVE DEVICE. THERE WERE NO CLINICAL AND ANGIOGRAPHIC EVENTS DETECTED DURING THE ENTIRE SHOCKWAVE PROCEDURE. APPROXIMATELY 30 MINUTES FOLLOWING SHOCKWAVE IVL, THE PATIENT EXPERIENCED AN ELECTROMECHANICAL DISSOCIATION (CARDIAC ARREST) AND SUBSEQUENTLY EXPIRED. THE PATIENT'S FAMILY REFUSED AN AUTOPSY THEREFORE THE EXACT CAUSE OF DEATH IS UNKNOWN. THE OPERATORS OF THE DEVICE BELIEVE THAT SHOCKWAVE WAS NOT AT FAULT AS THE RESULT AFTER THE PROCEDURE WAS GOOD. THE PATIENT'S FAMILY REFUSED AN AUTOPSY SO THE PHYSICIANS ARE NOT CLEAR AS TO THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977144 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC C2IVL3512 P210120O 00195451000102

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| O CUTTING BALLOON (UNKNOWN MFR)| SEMI-COMPLIANT BALLOON (UNKNOWN MFR)