BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25080092 · Received May 5, 2026

    Report

    Report Number
    1220648-2026-07462
    Event Type
    Death
    Date Received
    May 5, 2026
    Date of Event
    April 26, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF DEATH IS UNKNOWN BUT HAS BEEN CAPTURED AS THE DATE OF EXPLANT. IF ADDITIONAL INFORMATION BECOMES KNOWN, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE PUMP WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 0

    A4, A5, AND A6 ARE 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.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN A 55-YEAR-OLD MALE PATIENT PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE E CARDIOGENIC SHOCK. INFORMATION OBTAINED FROM THE BEDSIDE REGISTERED NURSE AND CARDIOTHORACIC SURGERY PHYSICIAN ASSISTANT INDICATED THE PATIENT WAS DIAGNOSED WITH ANOXIC BRAIN INJURY ON COMPUTED TOMOGRAPHY (CT) IMAGING, WITH THE PRIMARY INDICATION LISTED AS OTHER. THE PATIENT¿S PUPILS WERE FIXED AND DILATED. THERE WAS REPORTED CONCERN FOR AIR EMBOLISM DURING AN ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY PRIOR TO IMPELLA PLACEMENT, AS WELL AS A CARDIAC ARREST WITH CARDIOPULMONARY RESUSCITATION (CPR) PRIOR TO IMPELLA IMPLANTATION. GIVEN THE PATIENT¿S NEUROLOGIC PROGNOSIS AND CLINICAL CONDITION, CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. THE DEATH IS BEING CONSERVATIVELY REPORTED; HOWEVER, BASED ON THE AVAILABLE INFORMATION, THE OUTCOME IS MORE LIKELY ATTRIBUTABLE TO THE PATIENT¿S PRE-EXISTING ANOXIC BRAIN INJURY, SUSPECTED AIR EMBOLISM, AND CARDIAC ARREST PRIOR TO IMPELLA SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194305 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027858357 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death