BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24606516 · Received March 16, 2026

    Report

    Report Number
    1220648-2026-05328
    Event Type
    Death
    Date Received
    March 16, 2026
    Date of Event
    November 29, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. CORRECTED INFORMATION HAS BEEN PROVIDED IN D1. THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    56 YEAR-OLD MALE PATIENT TREATED FOR CHEST PAIN TWO DAYS PRIOR. RE-PRESENTS WITH CARDIOGENIC SHOCK AND WAS IMPLANTED WITH IMPELLA CP. AFTER INSERTION, PUMP SHOWS A HIGH PURGE ALARM, AND A PUMP STOP ENSUES. PHYSICIAN DECIDED TO REPLACE WITH NEW CP PUMP. PATIENT WAS TRANSFERRED FOR ADVANCED CARE, CONTINUES TO DECOMPENSATE, EXPERIENCES TACHYCARDIA AND MEDICATION CHANGES, AND THE PUMP WAS REPOSITIONED. PATIENT EXPIRED ON SUPPORT. IMPELLA TO BE CODED TO ARRHYTHMIA, MEDICATION CHANGES, REPOSITIONING, AND DEATH. DEATH WAS CODED CONSERVATIVELY AS THE PATIENTS CRITICAL DISEASE WAS THE LIKELY CAUSE AND IMPELLA DID NOT CONTRIBUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21231 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2025568966 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention| D