BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER

    MDR report key: 23918544 · Received December 29, 2025

    Report

    Report Number
    3015053858-2025-00160
    Event Type
    Death
    Date Received
    December 29, 2025
    Date of Event
    December 18, 2025
    Report Date
    December 29, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000010
    PMA / PMN Number
    P200039/S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 PATIENT'S DEATH COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. 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 LESION IN THE MID-LEFT ANTERIOR DESCENDING ARTERY (LAD) OF A PATIENT WITH COMPLEX CORONARY ARTERY DISEASE (LEFT MAIN LESION, HEAVILY CALCIFIED LAD LESIONS, AND CTOS OF THE CIRCUMFLEX AND RCA) WHO HAD PREVIOUSLY UNDERGONE OUTSIDE-HOSPITAL CATHETERIZATION WITH PLACEMENT OF A LEFT MAIN DES AFTER BEING DEEMED A POOR SURGICAL BYPASS CANDIDATE DUE TO PERICARDIAL CALCIFICATION AND SUBOPTIMAL GRAFT TARGETS. HE WAS READMITTED WITH RECURRENT ISCHEMIC SYMPTOMS AND TAKEN TO THE CARDIAC CATHETERIZATION LAB VIA RIGHT FEMORAL ACCESS WITHOUT DIFFICULTY. ANGIOGRAPHY WAS PERFORMED USING A VODA 4 GUIDE AND A RUNTHROUGH WIRE TO THE LAD; PRE-DILATION OF THE LAD WAS PERFORMED WITH A EUPHORA BALLOON, AND IVUS COULD NOT CROSS THE LAD BUT WAS PERFORMED IN THE LEFT MAIN, DEMONSTRATING A MINIMAL LUMEN AREA OF ROUGHLY 8 MM AND AREAS OF STENT MAL-APPOSITION. THREE RESOLUTE ONYX DRUG ELUTING STENTS (DES) WERE DEPLOYED TO THE DISTAL AND MID LAD, AND THE PREVIOUSLY PLACED 4.00×8 MM LEFT MAIN STENT WAS POST-DILATED PER IVUS GUIDANCE WITH A NONCOMPLIANT EUPHORA BALLOON UNTIL THE OPERATOR JUDGED EXPANSION ADEQUATE. PERSISTENT UNDER-EXPANSION IN THE MID LAD PROMPTED USE OF A C2+ IVL CATHETER. THE IVL PULSES WERE DELIVERED TO THE UNDER-EXPANDED SEGMENT OF THE STENT, AND THEN PROXIMALLY. AFTER IVL, ANGIOGRAPHY SHOWED TIMI 1 FLOW IN THE TREATED AREA, AND A FOURTH RESOLUTE ONYX STENT WAS PLACED; FINAL ANGIOGRAPHY DEMONSTRATED TIMI 3 FLOW WITH NO RESIDUAL STENOSIS, AND NO EVIDENCE OF EDGE DISSECTION, PERFORATION, OR RUPTURE. SHORTLY AFTER THE FINAL ANGIOGRAM THE PATIENT DEVELOPED ABRUPT BRADYCARDIA AND HYPOTENSION; FULL ACLS WAS INITIATED AND CONTINUOUS CPR WAS PERFORMED FOR OVER ONE HOUR, BUT THE PATIENT EXPIRED. THE CAUSE OF DEATH REMAINS UNDETERMINED. THERE WAS NO REPORTED MALFUNCTION OF THE SHOCKWAVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2259033 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC. C2PIVL3012 01A250401B 00195451000010

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other| R| D 0.014 180CM RUNTHROUGH GUIDE WIRE - TERUMO| 2.50X12MM EMERGE PTCA BALLOON - BOSTON SCIENTIFIC| 2.50X34MM RESOLUTE ONYX DES - MEDTRONIC| 2.50X38MM RESOLUTE ONYX DES - MEDTRONIC| 2.50X8MM RESOLUTE ONYX DES- MEDTRONIC| 2.75X15MM NC EUPHORA PTCA BALLOON - MEDTRONIC| 3.00X34MM RESOLUTE ONYX DES - MEDTRONIC| 4.50X6MM NC EUPHORA PTCA BALLOON - MEDTRONIC| 5FR GUIDE EXTENSION CATHETER - TELEFLEX| 6FR OPTICROSS IVUS IMAGING CATHETER - BOSTON SCI| 6FR VODA LEFT 4 GUIDE CATHETER - BOSTON SCIENTIFIC