BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24160602 · Received January 23, 2026

    Report

    Report Number
    1220648-2026-01381
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    January 18, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. NO PRODUCT WAS RECEIVED FOR EVALUATION. ISCHEMIA: THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    A5 IS UNKNOWN. 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.

    Description of Event or Problem · 0

    A 75-YEAR-OLD MALE WAS SUPPORTED WITH AN IMPELLA CP DEVICE FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE DEVICE (SN (B)(6); PC (B)(4); GU CASE (B)(4)) WAS INSERTED PERCUTANEOUSLY VIA THE RIGHT FEMORAL ARTERY ON (B)(6) 2026 AT 22:58. DURING SUPPORT, PULSES IN THE IMPELLA ACCESS LIMB BECAME ABSENT. THE PATIENT WAS TAKEN TO THE CATHETERIZATION LAB FOR EVALUATION OF DISTAL PERFUSION. NO DISTAL PERFUSION WAS IDENTIFIED, CONSISTENT WITH LIMB ISCHEMIA. THE CLINICAL TEAM ELECTED TO TRANSITION SUPPORT TO AN INTRA AORTIC BALLOON PUMP (IABP) WITH CONSIDERATION FOR ECMO IF NEEDED. THE IMPELLA CP WAS SUBSEQUENTLY REMOVED, AND AN IABP WAS PLACED VIA THE SAME RIGHT FEMORAL ACCESS SITE ON (B)(6) 2026 AT 22:13. THE PATIENT SURVIVED EXPLANT. ALTHOUGH THE ISCHEMIA RESOLVED AFTER INTERVENTION, THE EVENT REPRESENTS A SERIOUS INJURY WITH THE POTENTIAL TO CAUSE PERMANENT IMPAIRMENT IF UNTREATED. ISCHEMIA IS CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221677 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026753442

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention