BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 21691490 · Received March 25, 2025

    Report

    Report Number
    3015053838-2025-00050
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    February 26, 2025
    Report Date
    March 25, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    QMG
    UDI-DI
    00195451000034
    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 PERFORATION 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

    A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ALTHOUGH THE IVL PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO IVL MALFUNCTION, A POST-PROCEDURE ANGIOGRAM REVEALED A PERFORATION IN THE ARTERY. A PAPYRUS STENT WAS PLACED, AND UPON REMOVAL OF THE STENT DELIVERY SYSTEM, THE DELIVERY SYSTEM CAUGHT ON THE STENT CAUSING IT TO COLLAPSE, PREVENTING THE PLACEMENT OF AN ONYX DRUG-ELUTING STENT (DES) AS INITIALLY PLANNED. THE PATIENT'S CONDITION DETERIORATED AND WAS SENT TO SURGERY. AS OF THE DATE OF THIS REPORT, THE PATIENT IS RECOVERING WELL AND HAS HAD THE IMPELLA REMOVED. THE PHYSICIAN BELIEVES THAT THE PERFORATION WAS CAUSED BY SHOCKWAVE. HOWEVER, HE CLARIFIES THAT THE COMPLICATIONS AFTER AND LEADING TO THE PATIENT'S SURGERY WERE UNRELATED TO THE SHOCKWAVE IVL CATHETER. HE STATES THAT THE NEED FOR SURGERY WAS DUE TO THE DRUG-ELUTING STENT BECOMING STUCK ON THE PAPYRUS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319279 SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER QMG SHOCKWAVE MEDICAL, INC. C2PIVL4012 07A240819B 00195451000034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R IMPELLA - ABIOMED| ONYX DRUG-ELUTING STENT (DES) - MEDTRONIC| PAPYRUS STENT - UNKNOWN MANUFACTURER