BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 24000325 · Received January 8, 2026

    Report

    Report Number
    1220648-2026-00311
    Event Type
    Injury
    Date Received
    January 8, 2026
    Date of Event
    December 18, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011609
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: PPAE (ISCHEMIA): IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT : 1980801. DEVICE HISTORY BATCH: SUBCOMPONENT LOT : N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    B5 UPDATED WITH ADDITIONAL INFORMATION. PATIENT HEIGHT AND WEIGHT WAS UNKNOWN.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE ISCHEMIA OCCURRED FOLLOWING THE USE OF A THIRD-PARTY 16FR SHEATH. IMMEDIATELY AFTER INSERTION OF THE 16FR SHEATH, LOWER LIMB ANGIOGRAPHY WAS PERFORMED VIA THE SHEATH¿S SIDE PORT, WHICH CONFIRMED THE PRESENCE OF ISCHEMIA. DESPITE THIS FINDING, THE IMPELLA DEVICE WAS INSERTED FOR PRE-PCI. ISCHEMIA PERSISTED AFTER PCI, AND A COLD SENSATION WAS NOTED IN THE LEFT FOOT ON THE PUNCTURE SIDE. ALTHOUGH REVERSE INSERTION WAS CONSIDERED, THE PATIENT¿S VITAL SIGNS REMAINED STABLE; THEREFORE, THE SHEATH WAS REMOVED AT THE SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER REMOVAL, THE PUNCTURE SITE WAS SURGICALLY CLOSED. NO SPECIAL TREATMENT WAS REQUIRED, JUST A REGULAR PROCEDURE. NO IMAGING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63920 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA CP 2026748484 00813502011609

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention