BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24790106 · Received April 6, 2026

    Report

    Report Number
    1220648-2026-06423
    Event Type
    Death
    Date Received
    April 6, 2026
    Date of Event
    March 30, 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
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    UPON REVIEW, IT WAS IDENTIFIED THAT THE MANUFACTURER FAX (D3) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE FAX NUMBER HAS NOW BEEN PROVIDED. CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 SERIAL NUMBER. ADDED E1 ZIP CODE WAS OMITTED DURING INITIAL REPORT. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE TEMPORARY PUMP STOP ISSUE COULD NOT BE DETERMINED WITHOUT RETURNED PRODUCT INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING SUFFICIENT DATA LOGS. THE CAUSE OF THE PURGE PRESSURE HIGH ISSUE COULD NOT BE DETERMINED WITHOUT RETURNED PRODUCT INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOGS. THE CAUSE OF THE LOW OR BLOCKED PUMP FLOW ISSUE COULD NOT BE DETERMINED WITHOUT RETURNED PRODUCT INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOGS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED ALONG WITH THE RP FLEX FOR A BIPELLA SUPPORT OF THE 29 YEAR OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN FOR SURGERY. THE PATIENT SUFFERED FROM POST CARDIOTOMY CARDIOGENIC SHOCK AFTER THE CORONARY ARTERY BYPASS SURGERY (CABG) AND VALVE. THE PATIENT WAS KNOWN TO BE IN SCAI STAGE D SHOCK AT THE PUMP IMPLANT. THE PATIENT WAS PLACED ON THE BIPELLA AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND THEN SENT TO THE ICU FOR CONTINUED CARE AND MONITORING POSTOPERATIVELY. ON THE 4TH DAY OF SUPPORT THE TEAM OBSERVED SUCTION DESPITE APPROPRIATE VOLUME AND PUMP POSITION. THE TEAM DID REPOSITION THE PUMP AND INFUSED BLOOD VOLUME AND CLOTTING FACTORS. ALSO ON THIS 4TH DAY OF SUPPORT THERE WAS A TEMPORARY PUMP STOP. THEY WERE ABLE TO RESTART THE PUMP AND WHEN RESTARTED, THE HIGH PURGE PRESSURES OBSERVED PRIOR TO THE STOP HAD RESOLVED. THE SUPPORT PROCEEDED TIL CARE WAS WITHDRAWN AND PATIENT EXPIRED. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123249 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027827941 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1