BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP , JP

    MDR report key: 24059312 · Received January 13, 2026

    Report

    Report Number
    1220648-2026-00644
    Event Type
    Death
    Date Received
    January 13, 2026
    Date of Event
    December 18, 2025
    Report Date
    January 13, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED AND NO DEVICE WAS RETURNED. INVESTIGATION SUMMARY: PERIPHERAL ARTERY DISSECTION/PERIPHERAL ARTERY OCCLUSION: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. ACCESS SITE ADVERSE EVENT: THE CAUSE OF ASAE CANNOT BE DETERMINED SINCE INSUFFICIENT CLINICAL DETAILS WERE PROVIDED.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 87 YEAR OLD FEMALE ON AN IMPELLA CP FOR SUPPORT DUE TO ACUTE MYOCARDIAL INFARCTION. DURING THE PROCEDURE, CHRONIC TOTAL OCCLUSIONS WERE CONFIRMED IN BOTH THE RIGHT CORONARY ARTERY AND THE LEFT CIRCUMFLEX ARTERY, WITH CIRCUMFERENTIAL, SEVERE CALCIFIED LESIONS. CONSIDERING THE CONDITION OF THE LESION, PRIOR TO DILATION USING THE CUTTING BALLOON, AN INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS ADVANCED UNDER SUPPORT OF A GUIDE EXTENSION CATHETER, AND DILATION WAS ATTEMPTED; HOWEVER, RUPTURE WAS OBSERVED IN A TOTAL OF TWO IVL CATHETERS. DILATION WAS SUCCESSFULLY ACHIEVED WITH A THIRD IVL CATHETER, AFTER WHICH THE SUBJECT CUTTING BALLOON DEVICE WAS ADVANCED FOR DILATION. DURING RAPID PRESSURIZATION AND DILATION OF THE LESION UP TO 20 ATM, VASCULAR PERFORATION WAS CONFIRMED. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED BY OVERLAPPING IMPLANTATION OF COVERED STENTS. DUE TO THE PATIENT¿S POOR CONDITION, INITIATION OF ECMO WAS CONSIDERED; HOWEVER, THE PATIENT¿S FAMILY DECLINED LIFE-PROLONGING TREATMENT WITH ECMO. SUBSEQUENTLY, THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587 IMPELLA CP , JP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP , JP 2026786054

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Unknown Death| R