BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    MDR report key: 17250179 · Received July 3, 2023

    Report

    Report Number
    3015053858-2023-00043
    Event Type
    Death
    Date Received
    July 3, 2023
    Date of Event
    June 27, 2023
    Report Date
    June 27, 2023
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SHOCKWAVE MEDICAL, INC. FOR INVESTIGATION THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. BASED ON THE REPORTED EVENT, THE IVL TREATMENT WAS SUCCESSFUL. WHEN A 2ND SECOND DRUG-ELUTING STENT (DES) WAS IMPLANTED DUE TO THE LENGTH OF THE DISEASED VESSEL, A PERFORATION OCCURRED. THIS RESULTED IN PATIENT TO CODE AND SUBSEQUENTLY EXPIRED. 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 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A PATIENT WHO HAD A CHRONIC UNDER-EXPANDED STENT. ACCESS TO THE TARGET VESSEL WAS OBTAINED VIA THE FEMORAL ARTERY. THE PHYSICIAN WAS REPORTED TO BE AWARE THAT THE DEVICE WAS BEING USED OFF-LABEL. ACCORDINGLY, THE IVL TREATMENT WAS IN THE NATIVE VESSEL AND PART WAS INSIDE A CHRONIC UNDER-EXPANDED STENT. THE IVL BALLOON SUCCESSFULLY DELIVERED 80 PULSES. POST PROCEDURE, THE PHYSICIAN DEPLOYED A RESOLUTE DRUG-ELUTING STENT (DES) AND THE TREATED VESSEL LOOKED GOOD VIA ANGIOGRAPH IMAGING. BECAUSE OF THE LENGTH OF THE DISEASED VESSEL, A SECOND DES WAS DEPLOYED WHICH RESULTED IN VESSEL PERFORATION. IT IS UNKNOWN IF THE PERFORATION WAS TREATED BUT IT WAS REPORTED THAT THE PATIENT CODED AND SUBSEQUENTLY EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19918 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2IVL3512 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Death RESOLUTE ONYX DRUG-ELUTING STENT (DES) - MEDTRONIC