BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 22325626 · Received June 25, 2025

    Report

    Report Number
    3015053858-2025-00081
    Event Type
    Death
    Date Received
    June 25, 2025
    Date of Event
    May 19, 2025
    Report Date
    June 23, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    PPN
    UDI-DI
    00195451000256
    PMA / PMN Number
    K203365
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. BASED ON THE REPORTED INFORMATION, THERE WAS NO IVL MALFUNCTION AND NO INFORMATION SUGGESTING THE DEVICE CONTRIBUTED TO THE PATIENT DEATH. MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION RELATED TO THE EVENT WITH LIMITED INFORMATION TO DATE. 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. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 0

    A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED WAS USED TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. THE SHOCKWAVE CATHETER DELIVERED 300 PULSES AT A PULSE PRESSURE OF 4ATM SUCCESSFULLY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED COMPLICATIONS FOLLOWING STENT DELIVERY. IT WAS REPORTED THAT THE SHOCKWAVE DEVICE HAD NO IMPACT ON THE PATIENT'S COMPLICATIONS. ACCORDING TO THE MANAGEMENT TEAM, THE PATIENT DEATH OCCURRED POST PROCEDURE, AFTER BEING TRANSFERRED TO THE HEART CENTER. THERE WAS NO ADDITIONAL INFORMATION KNOWN AND/OR PROVIDED REGARDING THE EVENT. BASED ON THE INFORMATION PROVIDED, THE PROCEDURE WAS PERFORMED ON (B)(6) 2025 AND PATIENT DEATH OCCURRED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653657 SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER PPN SHOCKWAVE MEDICAL, INC. M5PIVL6060 82297848 00195451000256

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death| O BALLOON - MANUFACTURER UNKNOWN| STENTS - MANUFACTURER UNKNOWN