BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23705388 · Received December 3, 2025

    Report

    Report Number
    1220648-2025-48756
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    October 27, 2025
    Report Date
    January 5, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY. NO PRODUCT WAS RETURNED. VENTRICULAR TACHYCARDIA: IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. MAJOR BLEED: THE CAUSE OF THE GI BLEED WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE IN WRONG POSITION (POSITIONING ISSUE): THE CAUSE OF THE POSITIONING ISSUE WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT DEVICE LOT: 1932237 DEVICE HISTORY BATCH SUBCOMPONENT LOT: N/A DEVICE HISTORY REVIEW DEVICE (SN: 603364) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA 5.5 RECEIVED ONE UNIT OF PACKED RED BLOOD CELLS FOR HEMOGLOBIN AT 7.1 LABS WERE PENDING. NITROGLYCERIN WAS STARTED FOR AFTER LOAD REDUCTIONS. A FEW DAYS LATER, THE PATIENT EXPERIENCED PREMATURE VENTRICULAR CONTRACTIONS/SELF-LIMITING VENTRICULAR TACHYCARDIA AFTER INCREASED TO P7 YESTERDAY. TRANSTHORACIC ECHOCARDIOGRAM SHOWED IMPELLA CLOSE TO SEPTUM AND SIX CENTIMETERS ACROSS ATRIOVENTRICULAR. A DISCUSSION WITH SURGERY REGARDING PULLING BACK THE IMPELLA. THE PATIENT HAD VENTRICULAR FIBRILLATION IN THE OPERATING ROOM PRIOR TO THE IMPELLA. ADDITIONALLY, THE PATIENT SUFFERED GASTROINTESTINAL BLEEDING. ANTICOAGULANTS WERE WITHHELD. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2821873 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026692946 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention