BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25111602 · Received May 7, 2026

    Report

    Report Number
    1220648-2026-07628
    Event Type
    Death
    Date Received
    May 7, 2026
    Date of Event
    April 29, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013344
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B1, B2, B5, H1, H6 UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED.

    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.

    Description of Event or Problem · 0

    AN IMPELLA CP DEVICE WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN A 70-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS) ) WITH CARDIOPULMONARY RESUSCITATION (CPR), CLASSIFIED AS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE D SHOCK. THIS WAS THE FIRST USE OF AN IMPELLA CP GENERATION C9+ DEVICE BY THE OPERATOR. PER THE HEATLHCARE PROFESSIONAL, IT WAS REPORTED THAT CHEST RADIOGRAPH IMAGING OBTAINED ON DAY 0, DAY 1, AND DAY 3 DEMONSTRATED A DISTORTED PIGTAIL CONFIGURATION. THE CARE TEAM NOTED UNCERTAINTY AS TO WHETHER THE OBSERVED PIGTAIL APPEARANCE WAS RELATED TO THE SOFTER PIGTAIL DESIGN OF THE C9+ GENERATION COMPARED WITH PRIOR IMPELLA CP GENERATIONS. PER REVIEW OF THE AUTOMATED IMPELLA CONTROLLER (AIC), THERE WERE NO FREQUENT ALARMS OR EVENTS SUSPECTED TO BE ASSOCIATED WITH THE PIGTAIL CONFIGURATION. THE PATIENT REMAINED ON IMPELLA CP SUPPORT BEYOND THE INDICATED DURATION. ON DAY 8, THE PATIENT EXPIRED, AND THE IMPELLA CP DEVICE WAS EXPLANTED AT THE TIME OF DEATH. THE DEATH IS BEING CONSERVATIVELY REPORTED DUE TO TEMPORAL ASSOCIATION WITH IMPELLA CP SUPPORT BUT MORE LIKELY DUE TO CONTRIBUTING FACTORS INCLUDING ADVANCED CARDIOGENIC SHOCK (SCAI STAGE D), PROLONGED DOWNTIME PRIOR TO RETURN OF SPONTANEOUS CIRCULATION, CRITICAL ILLNESS REQUIRING EXTENDED MECHANICAL CIRCULATORY SUPPORT, AND SUPPORT DURATION BEYOND THE INDICATED USE FOR IMPELLA CP. PER THE ADVANCED SURGICAL CONSULTANT, THE CAUSE OF DEATH WAS ATTRIBUTED TO BRAIN STEM INJURY FOLLOWING PROLONGED DOWNTIME RELATED TO CARDIAC ARREST, RATHER THAN DEVICE PERFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN IMPELLA CP DISPLAYED A DISTORTED PIGTAIL. THE PATIENT REMAINS ON IMPELLA SUPPORT IN CRITICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572341 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027830765 00813502013344

    Patients

    Seq Age Sex Outcome Treatment
    1