BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24206131 · Received January 28, 2026

    Report

    Report Number
    1220648-2026-01759
    Event Type
    Injury
    Date Received
    January 28, 2026
    Date of Event
    December 24, 2025
    Report Date
    February 2, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: 2002795. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THIS PUMP SN (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    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

    AN IMPELLA CP DEVICE WAS PLACED IN A 72-YEAR-OLD FEMALE UNDERGOING HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION VIA FEMORAL ARTERY ACCESS. THE PATIENT HAD A MEDICAL HISTORY SIGNIFICANT FOR CORONARY ARTERY DISEASE AND RENAL FAILURE AND REQUIRED INOTROPIC AND VASOPRESSOR SUPPORT DURING TREATMENT. APPROXIMATELY EIGHT HOURS FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED ACUTE LIMB ISCHEMIA AND UNDERWENT SURGICAL INTERVENTION. THE REPORTED PATIENT EVENTS INCLUDED ISCHEMIA AND SURGICAL INTERVENTION. THESE EVENTS OCCURRED IN THE SETTING OF LARGE-BORE FEMORAL ACCESS, UNDERLYING VASCULAR DISEASE, RENAL FAILURE, AND THE USE OF INOTROPES AND VASOPRESSORS, WHICH ARE KNOWN TO CONTRIBUTE TO PERIPHERAL VASOCONSTRICTION AND ISCHEMIC COMPLICATIONS. BASED ON COMPREHENSIVE REVIEW OF THE AVAILABLE INFORMATION, THE REPORTED EVENTS ARE CONSISTENT WITH PATIENT-SPECIFIC AND PROCEDURAL RISK FACTORS. COMPREHENSIVE REVIEW DID NOT IDENTIFY EVIDENCE SUGGESTING A CAUSAL RELATIONSHIP BETWEEN THE IMPELLA CP DEVICE AND THE REPORTED PATIENT EVENTS. THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267748 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. PUMP 381 PUMP SET (US) 2026791149 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention