BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 21518564 · Received March 4, 2025

    Report

    Report Number
    3015053838-2025-00045
    Event Type
    Death
    Date Received
    March 4, 2025
    Date of Event
    February 5, 2025
    Report Date
    March 4, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000010
    PMA / PMN Number
    P200039/S008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. THEREFORE, A PHYSICAL EXAMINATION CANNOT BE PERFORMED. THE CAUSE OF THE REDUCED BLOOD FLOW, CHEST PAIN, AND SUBSEQUENT DEATH COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THE INTERVAL BETWEEN THE IVL TREATMENT AND THE PATIENT'S DEATH IS UNKNOWN. THE PROCEDURE WAS FINISHED SUCCESSFULLY, AND THE DRUG ELUTING STENTS WERE IMPLANTED AS INTENDED. THE CAUSE OF THE DEATH IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE CO-MORBIDITIES AND THE DEATH WAS NOT RELATED TO THE PCI PROCEDURE. 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 FOR SUBJECT LOT DOES NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL OF SHOCKWAVE MEDICAL, INC. ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

    Description of Event or Problem · 0

    A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A DENOVO LESION WITH NODULAR CALCIUM IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER 40 PULSES WERE DELIVERED, THE BALLOON LOST PRESSURE. POST IVL, A CUTTING/SCORING BALLOON WAS USED FOLLOWED BY THE PLACEMENT OF A DRUG ELUTING STENT (DES). THE PROCEDURE WAS FINISHED SUCCESSFULLY, AND THE DRUG ELUTING STENTS WERE IMPLANTED AS INTENDED. THE PATIENT, WHO HAD TRIPLE VESSEL DISEASE AND DIABETES, PASSED AWAY POST-PROCEDURE. IT WAS REPORTED THAT THE PATIENT MAY HAVE LOST SEPTAL FLOW, WHICH WAS SUPPORTING THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN PERFORMED A PERCUTANEOUS CORONARY INTERVENTION (PCI) BEFORE THE PATIENT EXPIRED. THE PATIENT DID NOT PASS AWAY IMMEDIATELY AFTER THE IVL TREATMENT AND SHOWED ONLY SLIGHT CHEST PAIN WHEN THE SEPTAL FLOW DECREASED. THE PATIENT EXPIRED DURING RECOVERY. THE ACCESS SITE WAS FEMORAL AND THE INTERVAL BETWEEN THE IVL TREATMENT AND THE PATIENT'S DEATH IS UNKNOWN. THE CAUSE OF THE DEATH IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE CO-MORBIDITIES AND THE DEATH WAS NOT RELATED TO THE PCI PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427892 SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2PIVL3012 01A240829B 00195451000010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death CUTTING/SCORING BALLOON - UNKNOWN MANUFACTURER.| XIENCE DRUG-ELUTING STENT (DES) - ABBOTT.