BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24648039 · Received March 20, 2026

    Report

    Report Number
    1220648-2026-05700
    Event Type
    Death
    Date Received
    March 20, 2026
    Date of Event
    March 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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; D4 (SERIAL); D10(CONCOMITANT MED PRODUCTS); E1; E3. THE CAUSE ACCESS SITE ADVERSE EVENT/MAJOR BLEED OF WAS MOST LIKELY PATIENT CONDITION RELATED SINCE THE CLINICAL TEAM CONFIRMED THE PATIENT HAD BLEEDING AT BOTH GROIN SITES.

    Additional Manufacturer Narrative · 0

    THE PUMP WAS DISCARDED. 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

    CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS INSERTED VIA RIGHT FEMORAL ARTERY IN A 62 YEAR OLD FEMALE FOR CARDIOMYOPATHY. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE E. THE PATIENT WAS ALSO RECEIVING VA-ECMO SUPPORT. ON DAY 2 OF CP SUPPORT, WHILE IN THE INTENSIVE CARE UNIT, THE PATIENT EXPERIENCED BLEEDING FROM BILATERAL GROIN SITES, BOTH THE IMPELLA AND ECMO SITES. THE PATIENT'S HEMOGLOBIN DROPPED TO 6.1 AND THE PATIENT WAS TRANSFUSED WITH 3 UNITS OF BLOOD. HEMOGLOBIN WAS THEN 9.5. ANTICOAGULATION WAS HELD AND UNKNOWN IF RESTARTED. ON DAY 6 OF SUPPORT, CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. THE DEVICE IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT¿S DEATH, WHICH WAS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CRITICAL CLINICAL CONDITION AS THEY PRESENTED WITH SCAI SHOCK STAGE E. THE REPORTED BLEEDING MAY OCCUR IN THE SETTING OF IMPELLA CP SUPPORT AND MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS THE UNDERLYING CARDIOGENIC SHOCK PHYSIOLOGY, HEMODYNAMIC INSTABILITY, AND ANTICOAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512723 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026812484 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Death| R ECMO EXTRACORPOREAL MEMBRANE OXYGENATION