BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23896599 · Received December 26, 2025

    Report

    Report Number
    1220648-2025-49279
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    September 18, 2025
    Report Date
    December 24, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DATA REVIEW: DATA LOGS CONFIRMED PUMP WAS IN IMPROPER POSITION CORRESPONDED WITH CLINICAL DESCRIPTION THAT TRIGGERED ALARMS IMPELLA POSITION IN VENTRICLE/AORTA. THERE WERE SUCTION ALARMS TRIGGERED IN EARLY OF THE CASE BUT RESOLVED QUICKLY NO OTHER ISSUES WERE FOUND ON THE LOGS. PRODUCT WAS NOT RETURNED FOR REVIEW. MECHANICAL INTERACTION WITH BLOOD: THE CAUSE OF MECHANICAL INTERACTION WITH BLOOD WAS MOST LIKELY DUE TO PUMP WAS NOT IN THE PROPER POSITION. THE CAUSE OF POSITIONING ISSUE IS UNKNOWN. DEVICE IN WRONG POSITION: THE CAUSE OF DEVICE IN WRONG POSITION WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR REVIEW. HEMATURIA: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT #: 1955298. DEVICE HISTORY BATCH: SUBCOMPONENT LOT#: N/A. DEVICE HISTORY REVIEW: PUMP SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT AN IMPELLA CP PUMP WAS IMPLANTED TO SUPPORT A PATIENT WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. THE PATIENT WAS SUCCESSFULLY PLACED ON THE IMPELLA CP DEVICE PRIOR TO PERCUTANEOUS CORONARY INTERVENTION (PCI). CATHETERIZATION LABORATORY (CCL) FOR DEVICE REMOVAL USING A MANTA VASCULAR CLOSURE DEVICE. A FOLEY CATHETER WAS IN PLACE, AND THE PATIENT¿S URINE APPEARED DARK AMBER IN COLOR. ECHOCARDIOGRAPHY DEMONSTRATED THAT THE IMPELLA CATHETER WAS POSITIONED BENEATH THE PAPILLARY MUSCLE. THE PHYSICIAN DECLINED TO REPOSITION THE DEVICE AND OPTED FOR REMOVAL, WITH CONSIDERATION OF POTENTIAL INTRA-AORTIC BALLOON PUMP (IABP) PLACEMENT. THE PATIENT¿S HEMODYNAMICS HAD IMPROVED FOLLOWING REMOVAL, AND NO ADDITIONAL MECHANICAL CIRCULATORY SUPPORT (MCS) DEVICE WAS PLACED. THE PATIENT¿S HEMODYNAMIC STATUS IMPROVED AFTER DEVICE REMOVAL. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT¿S SUBSEQUENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319783 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026718770 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention