BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER

    MDR report key: 23287480 · Received October 15, 2025

    Report

    Report Number
    3015053858-2025-00116
    Event Type
    Injury
    Date Received
    October 15, 2025
    Report Date
    October 13, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC
    Product Code
    QMG
    PMA / PMN Number
    P200039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 CHEST PAIN AND VESSEL OCCLUSION COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. THEREFORE, REVIEW OF THE DEVICE MANUFACTURING AND TEST DOCUMENTATION COULD NOT BE COMPLETED. HOWEVER, SHOCKWAVE MEDICAL, INC. HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    A LITERATURE REPORT, "SIDE BRANCH OCCLUSION AFTER INTRAVASCULAR LITHOTRIPSY: A CASE REPORT" VIA THE CUREUS JOURNAL OF MEDICAL SCIENCE, WAS RECEIVED BY SHOCKWAVE MEDICAL JAPAN. (DOI: HTTPS://WWW.CUREUS.COM/ARTICLES/398396-SIDE-BRANCH-OCCLUSION-AFTER-INTRAVASCULAR-LITHOTRIPSY-A-CASE-REPORT#!/). A PATIENT WHO UNDERWENT SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) FOR CORONARY CALCIFICATION EXPERIENCED CHEST DISCOMFORT AND OCCLUSION. AN 80-YEAR-OLD MALE PATIENT WITH STENTS IN THE DISTAL RIGHT CORONARY ARTERY AND PROXIMAL LEFT CIRCUMFLEX ARTERY UNDERWENT CORONARY ANGIOGRAPHY (CAG), REVEALING 75% STENOSIS OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC, HE WAS ADMITTED TO THE HOSPITAL FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) ON HIS OWN REQUEST. TWELVE-LEAD ELECTROCARDIOGRAPHY (ECG) WAS PERFORMED, FOLLOWED BY OPTICAL COHERENCE TOMOGRAPHY (OCT) WHICH SHOWED A MINIMUM LUMEN AREA (MLA) AND SEVERE CALCIFICATION, INDICATING THAT CONVENTIONAL BALLOON DILATATION WOULD LIKELY BE INSUFFICIENT TO ACHIEVE ADEQUATE EXPANSION, THUS JUSTIFYING THE USE OF INTRAVASCULAR LITHOTRIPSY (IVL). EIGHT (8) CYCLES OF IVL USING A 2.5X12 MM SHOCKWAVE C2 CORONARY IVL CATHETER (3015053858-2025-00116) WERE APPLIED FROM THE BIFURCATION OF THE FOURTH DIAGONAL BRANCH TO THE PROXIMAL LAD, FOLLOWED BY EIGHT (8) CYCLES OF IVL USING A 3.0X12 MM SHOCKWAVE C2 CORONARY IVL CATHETER (3015053858-2025-00117) TO THE PROXIMAL LAD WHICH SHOWED FRACTURING OF THE CALCIFICATION AND ENLARGEMENT OF THE MLA TO ON OCT. PRE-DILATION WAS PERFORMED USING A SCORING BALLOON FOR THE DISTAL SIDE AND A NON-COMPLIANT (NC) BALLOON FOR THE PROXIMAL SIDE. AFTER CONFIRMING VESSEL EXPANSION ON OCT, A DRUG-ELUTING STENT WAS DEPLOYED, FOLLOWED BY PROXIMAL STENT POST-DILATATION WITH A NC BALLOON. THE PATIENT COMPLAINED OF CHEST DISCOMFORT, AND THE ECG SHOWED SEGMENT TRANSIENT (ST) ELEVATION. ANGIOGRAPHY REVEALED A SUB-OCCLUSION OF THE FIRST DIAGONAL BRANCH AND AN OCCLUSION OF THE THIRD DIAGONAL BRANCH. A WIRE WAS PASSED THROUGH THE THIRD DIAGONAL BRANCH, AND KISSING BALLOON INFLATION WAS PERFORMED WITH A SEMI-COMPLIANT BALLOON IN THE THIRD DIAGONAL BRANCH AND A NON-COMPLIANT BALLOON IN THE MAIN VESSEL. THE FINAL ANGIOGRAPHY SHOWED IMPROVED FLOW IN THE THIRD DIAGONAL BRANCH, WITH RESOLUTION OF CHEST SYMPTOMS AND ECG CHANGES. THE PATIENT REMAINED ASYMPTOMATIC AND NO ECG CHANGES WERE OBSERVED, NO ADDITIONAL INTERVENTION WAS UNDERTAKEN. POSTOPERATIVE OCT REVEALED THAT THE OSTIA OF VESSELS HAD BEEN NARROWED BY FRACTURED CALCIFICATIONS, IMPAIRING FLOW. AFTER PCI, CONTINUOUS INTRAVENOUS INFUSION OF UNFRACTIONATED HEPARIN AND NICORANDIL WAS ADMINISTERED FOR 24 HOURS. CREATINE KINASE PEAKED 13 HOURS AFTER PCI AND SUBSEQUENTLY SHOWED A DECLINING TREND. AS THE PATIENT REMAINED ASYMPTOMATIC AND THE LABORATORY MARKERS IMPROVED, HE WAS DISCHARGED ON POSTOPERATIVE DAY 2. DUAL ANTIPLATELET THERAPY WITH PRASUGREL AND ASPIRIN WAS CONTINUED FOR THREE (3) MONTHS AFTER DISCHARGE, FOLLOWED BY PRASUGREL MONOTHERAPY. ROUTINE FOLLOW-UP CAG WAS NOT PERFORMED OWING TO THE PATIENT'S ADVANCED AGE; HOWEVER, HE REMAINED CARDIOVASCULAR EVENT-FREE DURING THE ONE-YEAR FOLLOW-UP PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187533 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other| H 1.5X10 MM SEMI-COMPLIANT BALLOON - UNKNOWN MFR.| 2.5X13 MM SCORING BALLOON - UNKNOWN MANUFACTURER.| 2.5X38 MM EVEROLIMUS-ELUTING STENT - ABBOTT.| 3.0X15 MM NON-COMPLIANT BALLOON - UNKNOWN MFR.| 3.0X15 MM NON-COMPLIANT BALLOON - UNKNOWN MFR.| 3.0X15 MM NON-COMPLIANT BALLOON - UNKNOWN MFR.| GUIDEWIRE - UNKNOWN MANUFACTURER.