BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER

    MDR report key: 25058159 · Received May 1, 2026

    Report

    Report Number
    3015053858-2026-00040
    Event Type
    Death
    Date Received
    May 1, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 5, 2026
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    PMA / PMN Number
    P200039/S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DEATH COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. REVIEW OF THE EVENT BY SHOCKWAVE MEDICAL SAFETY AND MEDICAL AFFAIRS DETERMINED THAT THE CORONARY PERFORATION OCCURRED INTRA-PROCEDURALLY DURING POST IVL NON-COMPLIANT (NC) BALLOON INFLATION AND IS THEREFORE CONSIDERED CAUSALLY RELATED TO THE PROCEDURE. DUE TO INSUFFICIENT DETAIL, DEVICE RELATEDNESS CANNOT BE FULLY EVALUATED; HOWEVER, THIS EVENT IS CONSERVATIVELY ASSESSED AS POSSIBLY RELATED TO THE DEVICE. THE PATIENT PASSED AWAY; HOWEVER, THE CAUSE OF DEATH WAS NOT PROVIDED. BASED ON THE LIMITED INFORMATION AVAILABLE, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT, DEVICE USE, AND THE PATIENT'S DEATH CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 01MAY 2026 WAS ADDED TO SECTION B5.

    Description of Event or Problem · 0

    A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE CORONARY ARTERY. IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE PHYSICIAN CLARIFIED THAT THE ADVERSE EVENT DID NOT OCCUR DURING USE OF THE SHOCKWAVE C2+ IVL CATHETER. ACCORDING TO THE PHYSICIAN, THE LESION HAD YIELDED FOLLOWING IVL TREATMENT, AND A VESSEL PERFORATION OCCURRED DURING SUBSEQUENT POST DILATION WITH A NON-COMPLIANT (NC) BALLOON. THE PHYSICIAN BELIEVED THAT PROCEEDING WITH NC BALLOON INFLATION AFTER LESION YIELD WAS THE CONTRIBUTING FACTOR TO THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT IMAGING PERFORMED AFTER SHOCKWAVE DEVICE USE DEMONSTRATED NO VESSEL INJURY AT THAT TIME. THE PHYSICIAN THEN PROCEEDED WITH THE NON-COMPLIANT (NC) BALLOON, AND THE VESSEL PERFORATION WAS REPORTED TO HAVE OCCURRED AT NOMINAL PRESSURE. AN ATTEMPT WAS MADE TO OBTAIN A COVERED STENT TO TREAT THE PERFORATION. THE PATIENT PASSED AWAY SHORTLY AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482222 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC. C2PIVL3512 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death NON-COMPLIANT BALLOON - UNKNOWN MANUFACTURER.