BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH THE SHOCKWAVE M5+

    MDR report key: 18080499 · Received November 6, 2023

    Report

    Report Number
    3015053858-2023-00062
    Event Type
    Injury
    Date Received
    November 6, 2023
    Date of Event
    October 20, 2023
    Report Date
    May 19, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    PPN
    UDI-DI
    00195451000270
    PMA / PMN Number
    K203365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 NO INVESTIGATION CAN BE PERFORMED. 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. SHOCKWAVE MEDICAL HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN M5PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON CATHETER SUCCESSFULLY DELIVERED 120 PULSES IN THE ILIAC ARTERY. HOWEVER, AFTER ANGIOGRAM WAS PERFORMED, IT WAS NOTED THAT SOME DISTAL EMBOLI WAS OBSERVED IN THE POSTERIOR TIBIAL ARTERY. THE PHYSICIAN ASPIRATED THE EMBOLI USING THE PENUMBRA'S INDIGO ® ASPIRATION SYSTEM. IT WAS REPORTED THAT THERE WAS NOTHING HARD IN THE CHAMBER AND MOST LIKELY THE EMBOLIZATION WAS A THIN MATERIAL. THE IVL TREATMENT ACHIEVED GOOD RESULTS. THERE WAS NO REPORT OF IVL CATHETER MALFUNCTION. IT WAS MENTIONED THAT THE ARTERIES HAD RING STRIPPING, A FORM OF INTERVENTION MANY YEARS AGO SO THE INTIMA AND MEDIA WERE VERY FRAGILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349850 SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH THE SHOCKWAVE M5+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER PPN SHOCKWAVE MEDICAL, INC. 7.0X60MM A220916B 00195451000270

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other PENUMBRA'S INDIGO ® ASPIRATION SYSTEM - PENUMBRA