BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24557709 · Received March 10, 2026

    Report

    Report Number
    1220648-2026-04881
    Event Type
    Death
    Date Received
    March 10, 2026
    Date of Event
    February 27, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 WEIGHT IS UNKNOWN. 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 HAS BEEN PROVIDED IN D1 BRAND NAME. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE LOW OR BLOCKED PUMP FLOW ISSUE COULD NOT BE DETERMINED WITHOUT THE RETURNED PRODUCT FOR INVESTIGATION AND SUFFICIENT CLINICAL DETAILS SINCE THE DATA LOG ALONE IS NOT SUFFICIENT TO DERIVE CAUSE OF THE FLOW ISSUE. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL RATIONALE (REVISED): AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN AN 80-YEAR-OLD FEMALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE E, WITH A HISTORY OF PRIOR CORONARY ARTERY BYPASS GRAFTING (CABG), KNOWN CORONARY ARTERY DISEASE (CAD), DIABETES MELLITUS (DM), AND RENAL INSUFFICIENCY. THE PATIENT PRESENTED AS A STEMI, WITH CHRONIC TOTAL OCCLUSION (CTO) OF THE LAD. CARDIAC CATHETERIZATION LAB STAFF REPORTED THAT ¿HER LAD WAS PERFORATED.¿ THE PATIENT RECEIVED BASIC LIFE SUPPORT (BLS) AND ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS) BOTH PRIOR TO ARRIVAL AND IN THE CATHETERIZATION LABORATORY BEFORE AND AFTER IMPELLA PLACEMENT. DURING THE BRIEF PERIOD THE PATIENT WAS SUPPORTED ON IMPELLA, SUCTION ALARMS WERE NOTED. AFTER DISCUSSION WITH THE FAMILY, CARDIOLOGY CALLED THE CODE, AND TIME OF DEATH WAS DECLARED. THE REPORTED EVENTS INCLUDE LOW PUMP FLOW AND DEATH. THE DEATH WILL BE CONSERVATIVELY REPORTED TO THE IMPELLA CP; HOWEVER, THE DEVICE IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT¿S DEATH, WHICH WAS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CRITICAL CONDITION, INCLUDING LAD PERFORATION, PROFOUND CARDIOGENIC SHOCK, AND RECURRENT CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46443 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026778416 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Death