BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO CORONARY IVL CATHETER

    MDR report key: 24781042 · Received April 3, 2026

    Report

    Report Number
    3015053858-2026-00033
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 29, 2026
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000591
    PMA / PMN Number
    P200039/S015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 03APR2026 WAS ADDED TO SECTION B5.

    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 NSTEMI COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. 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

    POST-PROCEDURE, AFTER USE OF THREE SHOCKWAVE JAVELIN DEVICES, THE LESION REMAINED HEAVILY CALCIFIED, AND ANGIOGRAPHIC IMAGING DEMONSTRATED APPROXIMATELY 60% RESIDUAL STENOSIS. AFTER DECIDING THAT THE SEVERELY CALCIFIED LESION NEEDED FURTHER MODIFICATION, IT WAS DECIDED TO USE A SHOCKWAVE C2 AERO CATHETER. THE PHYSICIAN STARTED WITH A 2.5 MM SHOCKWAVE C2 AERO CATHETER AND THEN USED A 3.0 MM SHOCKWAVE C2 AERO CATHETER. IT WAS REPORTED THAT THE REASON FOR THE SECOND C2 AERO WAS FURTHER MODIFICATION OF THE LESION. AFTER THE C2 AERO CATHETERS WERE USED, TWO ANGIOGRAPHIC IMAGES WERE PERFORMED DEMONSTRATING A 20% RESIDUAL STENOSIS. OVERALL, SHOCKWAVE LITHOTRIPSY REDUCED THE RESIDUAL STENOSIS FROM 60% POST JAVELIN TO 20% POST C2 AERO. THE LESION MODIFICATION ALLOWED FOR ADEQUATE STENT EXPANSION, AND SUBSEQUENT POSTDILATION ALLOWED FULL STENT EXPANSION.

    Description of Event or Problem · 0

    THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE PRE-MARKET FORWARD CAD IDE STUDY. THREE INVESTIGATIONAL SHOCKWAVE JAVELIN CORONARY (ARTEMIS) INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS AND TWO NON-INVESTIGATIONAL SHOCKWAVE C2 AERO CORONARY IVL CATHETERS WERE USED DURING AN IVL PROCEDURE ON (B)(6) 2026. THIS REPORT DOCUMENTS THE ADVERSE EVENT REPORTED IN ASSOCIATION WITH THE USE OF THE TWO SHOCKWAVE C2 AERO CORONARY IVL CATHETERS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN FOLLOWING THE PROCEDURE AND HAD A TRANSIENT HYPOTENSIVE EPISODE WITH BLOOD PRESSURE READINGS OF 84/61 MMHG AND 76/53 MMHG, WHICH RESOLVED SPONTANEOUSLY. THE INITIAL POST-PROCEDURE ECG (ELECTROCARDIOGRAM) DEMONSTRATED A NONSPECIFIC ST SEGMENT ABNORMALITY, WHILE SUBSEQUENT SECOND AND THIRD ECGS SHOWED INFERIOR ST SEGMENT ELEVATION. THE PATIENT WAS TAKEN TO THE CATHETERIZATION LABORATORY (CATH LAB), WHERE A DIAGNOSTIC CORONARY ANGIOGRAM WAS PERFORMED. UPON THE PATIENT'S RETURN FROM THE CATH LAB, STUDY MANDATED CARDIAC BIOMARKERS WERE COLLECTED PER PROTOCOL, AS 12 HOURS HAD ELAPSED SINCE THE INDEX PROCEDURE. RESULTS SHOWED: CK MB (CREATINE KINASE-MYOCARDIAL BAND): 25.1 NG/ML (UPPER LIMIT OF NORMAL (ULN): 7.8 NG/ML) TROPONIN T HS (HIGH SENSITIVITY TROPONIN T): 248 NG/ML (ULN: 15 NG/ML) THE PATIENT WAS ADMINISTERED NITROGLYCERIN 0.4 MG (SUBLINGUAL), MORPHINE 4 MG (IV), AND METOPROLOL TARTRATE 5 MG (IV) TO TREAT THE ADVERSE EVENT. THE PATIENT DENIED CHEST PAIN AFTER THE PROCEDURE AND AT DISCHARGE. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2026. THE CLINICAL STUDY SITE DETERMINED THAT THE NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WAS POSSIBLY RELATED TO THE STUDY DEVICES AND DEFINITELY RELATED TO THE PROCEDURE. THIS REPORT IS FOR THE FIRST CATHETER USED IN THE PROCEDURE. THE SECOND CATHETER IS BEING REPORTED IN MDR #3015053858-2026-00034.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114084 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 AERO CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC. C2AIVL2512 03A251126A 00195451000591

    Patients

    Seq Age Sex Outcome Treatment
    1