BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24545755 · Received March 9, 2026

    Report

    Report Number
    1220648-2026-04765
    Event Type
    Death
    Date Received
    March 9, 2026
    Date of Event
    November 30, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. MULTI-PUMP CASE: PUMP 1 CP - (B)(4), PUMP 2 RP FLEX -(B)(4).

    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 CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    A 60 YEAR OLD FEMALE PATIENT WITH CARDIOGENIC SHOCK IMPLANTED WITH BOTH IMPELLA CP AND RP FLEX FOR BIVENTRICULAR SUPPORT. PATIENT CONTINUED TO DECOMPENSATE. VAGINAL BLEEDING OF UNKNOWN ORIGIN NOTED (PATIENT HAD OBGYN APPOINTMENT DAY PRIOR). PATIENT NOT IMPROVING, AND HIGH PRESSURE ALARM NOTED ON RP FLEX PUMP. OFF LABEL TPA PROTOCOL ADMINISTERED IN THE PURGE. DESPITE EFFORTS FAMILY DECIDED TO WITHDRAW CARE. IMPELLA CP AND RP FLEX TO BE CODED TO MINOR BLEEDING AND DEATH, AND RP FLEX TO BE CODED TO MEDICATION CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134662 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026757646 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention| D