BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23605578 · Received November 20, 2025

    Report

    Report Number
    1220648-2025-48507
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    October 21, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND NOT SAVED BY THE FACILITY AND IS THEREFORE UNAVAILABLE FOR RETURN TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: TYPE OF INVESTIGATION, ADDED CODES B11 AND B13. H11: ADDED THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY NO PRODUCT WAS RETURNED FOR INVESTIGATION. VENTRICULAR TACHYCARDIA: IN ORDER TO MAKE A ROOT CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS 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: 1970125. DEVICE HISTORY REVIEW: DEVICE WITH SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT PRESENTED TO THE HOSPITAL WITH CHEST PAIN AND A LEFT HEART CATHETERIZATION REVEALED LESIONS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND RIGHT CORONARY ARTERY (RCA). ONE DRUG ELUTING STENT WAS PLACED IN THE LAD AND ONE IN THE RCA. FOLLOWING THE CORONARY INTERVENTION, AN IMPELLA CP WAS PLACED VIA THE RIGHT FEMORAL ARTERY WITH NO COMPLICATIONS AND THE PATIENT WAS SENT TO THE UNIT FOR REST AND RECOVERY. ON DAY THREE OF SUPPORT, IT WAS REPORTED THAT THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA THAT SELF-RESOLVED. AMIODARONE WAS ADMINISTERED AS A RESULT OF THE ARRHYTHMIA AND ADDITIONALLY THE PATIENT WAS ADMINISTERED LEVOPHED TO ACHIEVE A MEAN ARTERIAL PRESSURE GREATER THAN 60 MMHG. THE DEVICE WAS EXPLANTED SUCCESSFULLY AFTER WEANING. THE EXPLANT WAS NOT CONSIDERED PREMATURE AND WAS UNRELATED TO THE REPORTED COMPLICATION. THE PATIENT'S OUTCOME AT THE TIME OF EXPLANT WAS SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2662431 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026732059 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention