BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY CATHETER

    MDR report key: 17290260 · Received July 10, 2023

    Report

    Report Number
    3015053858-2023-00044
    Event Type
    Death
    Date Received
    July 10, 2023
    Date of Event
    June 26, 2023
    Report Date
    June 26, 2023
    Manufacturer
    SHOCKWAVE MEDICAL, INC
    Product Code
    PPN
    UDI-DI
    00195451000409
    PMA / PMN Number
    K221852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES REFERENCED IN THIS REPORT WERE NOT RETURNED TO SHOCKWAVE MEDICAL, INC. FOR INVESTIGATION. THEREFORE, INSPECTION OF THE DEVICE COULD NOT BE PERFORMED. BASED ON THE REPORTED INFORMATION, THERE WAS NO IVL DEVICE MALFUNCTION. THE PHYSICIAN BELIEVES THAT IT WAS THE STEEL CORE .018 WIRE THAT PERFORATED THE LV. THE IVL DEVICE WAS USED OFF LABEL IN AN UNAPPROVED INDICATION. PER THE INSTRUCTIONS FOR USE (IFU), THE DEVICE IS ONLY INDICATED FOR USE IN THE PERIPHERAL VASCULATURE, INCLUDING THE ILIAC, FEMORAL, ILIO-FEMORAL, POPLITEAL, INFRA-POPLITEAL, AND RENAL ARTERIES. A REVIEW OF THE LOT HISTORY RECORDS (LHRS) AND TEST DOCUMENTATION DID NOT SHOW ANY ISSUES WITH THE MANUFACTURING OF THE DEVICES. THE DEVICES 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. 2ND DEVICE USED DURING PROCEDURE: CP-11575. LOT NUMBER: A221214A. EXPIRATION DATE: 12/31/2024. MANUFACTURING DATE: 12/14/2022. 3RD DEVICE USED DURING PROCEDURE: CP-11576. LOT NUMBER: A221214A. EXPIRATION DATE: 12/31/2024. MANUFACTURING DATE: 12/14/2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A MITRAL VALVULOPLASTY PROCEDURE TO TREAT MITRAL STENOSIS USING THREE SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY CATHETERS. THE PROCEDURE WAS PERFORMED OFF-LABEL AND THE PHYSICIAN WAS AWARE OF IT. THE IVLS WERE INTRODUCED INTO THE PATIENT VIA TRANSSEPTAL PUNCTURE. DURING THE PROCEDURE AND AFTER 60 PULSES WERE DELIVERED, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN IMMEDIATELY REALIZED THAT THE 0.018" STEEL CORE WIRE PERFORATED THE LEFT VENTRICLE (LV). THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM (OR) FOR OPEN-HEART SURGERY TO FIX THE PERFORATION AND THEN MOVED TO THE INTENSIVE CARE UNIT (ICU). WHILE IN THE ICU, THE PATIENT STARTED TO BLEED AGAIN AND THEN SUBSEQUENTLY EXPIRED. ALL THREE IVL DEVICES FUNCTIONED AS INTENDED AND NO MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693456 SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY CATHETER SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY CATHETER PPN SHOCKWAVE MEDICAL, INC L6IVL100030 A221214A 00195451000409

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death 0.018" STEELE CORE WIRE - ABBOTT VASCULAR