BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24764834 · Received April 2, 2026

    Report

    Report Number
    1220648-2026-06285
    Event Type
    Death
    Date Received
    April 2, 2026
    Date of Event
    March 26, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4 (SERIAL NUMBER). UPON REVIEW, THE SECTION D SERIAL NUMBER HAS NOW BEEN UPDATED. CORRECTED INFORMATION WAS PROVIDED IN E3 (INITIAL REPORTER OCCUPATION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY SUBMITTED IN ERROR IN THE INITIAL REPORT. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE ISSUE WAS NOT ESTABLISHED AS NO PRODUCT OR LOGS WERE RETURNED FOR ANALYSIS AND LIMITED CLINICAL INFORMATION WAS PROVIDED. THE CAUSE OF THE ISSUE WAS UNABLE TO BE DEFINITIVELY DETERMINED AS LIMITED CLINICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN AN 88-YEAR-OLD FEMALE PATIENT PRESENTING FOR HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI), SCAI SHOCK STAGE D. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE BEDSIDE NURSE REPORTED PINK-TINGED URINE THAT HAD IMPROVED FROM PREVIOUSLY RED URINE. BLEEDING WAS REPORTED FROM MULTIPLE SITES, INCLUDING THE IMPELLA ACCESS SITE. THE PATIENT RECEIVED BLOOD PRODUCTS, AND SYSTEMIC ANTICOAGULATION WAS PLACED ON HOLD. CARE WAS SUBSEQUENTLY WITHDRAWN, AND THE PATIENT EXPIRED. THE REPORTED HEMOLYSIS IS CONSISTENT WITH HEMOCOMPATIBILITY-RELATED FINDINGS THAT MAY OCCUR DURING MECHANICAL CIRCULATORY SUPPORT AND MAY BE INFLUENCED BY UNDERLYING HEMODYNAMIC INSTABILITY, ANTICOAGULATION EFFECTS, AND CRITICAL ILLNESS. THE REPORTED MAJOR BLEED IS CONSISTENT WITH ACCESS-SITE AND SYSTEMIC BLEEDING COMPLICATIONS IN THE SETTING OF MECHANICAL CIRCULATORY SUPPORT AND ANTICOAGULATION MANAGEMENT. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, GIVEN THE PATIENT¿S PRESENTATION WITH ADVANCED CARDIOGENIC SHOCK (SCAI SHOCK STAGE¿D) AND OVERALL CLINICAL DETERIORATION, THE DEATH IS MOST LIKELY ATTRIBUTABLE TO THE SEVERITY OF THE PATIENT'S UNDERLYING CRITICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608888 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027843109 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1