BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 22583527 · Received July 23, 2025

    Report

    Report Number
    3015053858-2025-00090
    Event Type
    Injury
    Date Received
    July 23, 2025
    Report Date
    July 23, 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, ABRUPT VESSEL CLOSURE, HEMATOMA, DISSECTION, CARDIAC ENZYME ELEVATION AND MYOCARDIAL INFARCTION COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. 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 WAS RECEIVED BY SHOCKWAVE MEDICAL VIA THE "CORONARY ARTERY DISEASE" PUBLICATION: (DOI: 10.1097/MCA.0000000000001542). A 72-YEAR-OLD WOMAN WITH STABLE ANGINA UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR SIGNIFICANT STENOSIS IN HER MID-LEFT ANTERIOR DESCENDING ARTERY (LAD). INTRAVASCULAR ULTRASOUND (IVUS) REVEALED A CONCENTRIC SEVERELY CALCIFIED LESION. AFTER PREDILATING THE ARTERY WITH A 2.0-MM NONCOMPLIANT BALLOON, A SHOCKWAVE MEDICAL C2 CORONARY 2.5 × 12 MM INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO DELIVER 80 PULSES AT THE CALCIFIED LESION - A 25-MM AREA CENTERED ON THE CULPRIT LESION, WHICH EXHIBITED CONCENTRIC CALCIFICATION BY IVUS. DURING IVL, THE ST-T SEGMENT IN THE V2-V3 LEADS OF THE ELECTROCARDIOGRAM BECAME ELEVATED, AND THE PATIENT COMPLAINED OF CHEST PAIN. CORONARY ANGIOGRAPHY SHOWED ABRUPT CLOSURE IN THE DISTAL LAD. NEXT, IVUS REVEALED A TINY TRUE LUMEN COMPRESSED BY THE HEMATOMA FROM THE CULPRIT LESION TO THE DISTAL LAD AT THE APEX. IT IS SPECULATED THAT THE ENTRY POINT OF DISSECTION WAS THE CULPRIT CALCIFIED LESION SITE WHERE THE IVL TREATMENT WAS PERFORMED; THEREFORE, A BOSTON SCIENTIFIC 3.0 × 38 MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED IN THE CULPRIT LESION TO CLOSE THE DISSECTION ENTRY; HOWEVER, THE ST-T ELEVATION DID NOT RESOLVE. THE DISTAL-ENDPOINT VESSEL DIAMETER AT THE HEMATOMA WAS 2.8 MM BY IVUS. THEREFORE, A NIPRO 2.5 × 9 MM NSE APERTA NOVEL NONCOMPLIANT SCORING BALLOON CATHETER WITH THREE PLASTIC ELEMENTS WAS DELIVERED TO THE APEX PORTION OF THE VESSEL WITHOUT PERFORMING THE PRE-DILATATION FOR THE ANGULATED VESSEL AND INFLATED TO 14 ATM TO ACHIEVE FENESTRATION DURING DISSECTION. THE NSE APERTA CATHETER WAS CONSTRUCTED WITH THREE HIGH ELEMENTS 120° APART ON A NONCOMPLIANT BALLOON. THE CONNECTION BETWEEN THE TRUE AND FALSE LUMENS WAS IDENTIFIED BY IVUS. THE ST-T SEGMENT OF THE V2-V3 LEADS NORMALIZED AFTER THE FENESTRATION. SUBSEQUENT ANGIOGRAPHY SHOWED THROMBOLYSIS IN MYOCARDIAL INFARCTION THREE FLOW DESPITE THE SPIRAL DISSECTION CREATED BY THE IVL AND THE FINAL IVUS CONFIRMED A DILATED TRUE LUMEN. ALTHOUGH THE PATIENT'S TROPONIN I WAS ELEVATED (2103 PG/ML), HER CREATINE KINASE WAS NORMAL (186 U/L) ON POSTOPERATIVE DAY 1. NO CLINICAL EVENTS WERE OBSERVED 6 MONTHS AFTER PCI, AND COMPUTED TOMOGRAPHY CORONARY ANGIOGRAPHY REVEALED HEALING OF THE TARGET LAD. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. THE DATE OF THE PROCEDURE AND DEVICE INFORMATION ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717089 SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other 2.0-MM NONCOMPLIANT BALLOON - MANUFACTURER UNKNOWN| 2.5 × 9 MM NSE APERTA NC SCORING BALLOON - NIPRO| 3.0 × 38 MM SYNERGY XD DES - BOSTON SCIENTIFIC