BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24857112 · Received April 13, 2026

    Report

    Report Number
    1220648-2026-06669
    Event Type
    Death
    Date Received
    April 13, 2026
    Date of Event
    April 3, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. CORRECTED INFORMATION WAS PROVIDED IN B1 AND D3. UPON REVIEW, IT WAS IDENTIFIED THAT THESE WERE INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4. UPON REVIEW, THE PRIMARY UDI NUMBER HAS BEEN UPDATED.

    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 HAS BEEN PROVIDED IN D4. HIGH PURGE PRESSURE: THE CAUSE OF THE HIGH PURGE PRESSURE COULD NOT BE DETERMINED AS NO PRODUCT OR LOGS WERE RETURNED FOR EVALUATION. MECHANICAL INTERACTION WITH BLOOD/HEMOLYSIS: THE CAUSE OF THE MECHANICAL INTERACTION WITH BLOOD/HEMOLYSIS COULD NOT BE DETERMINED AS NO PRODUCT OR LOGS WERE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    A 64 YEAR OLD MALE WITH POSTCARDIOTOMY CARDIOGENIC SHOCK (PCCS) AND A PRE SUPPORT CLINICAL CONDITION CONSISTENT WITH SCAI SHOCK STAGE D WAS SUPPORTED WITH AN IMPELLA RP FLEX (IMPLANTED (B)(6) 2026 VIA RIGHT INTERNAL JUGULAR VEIN) AND AN IMPELLA 5.5 FLEX (IMPLANTED (B)(6) 2026 VIA LEFT AXILLARY ARTERY). ON (B)(6)2026, IMMEDIATELY AFTER A PURGE CASSETTE CHANGE ON THE IMPELLA RP FLEX, THE ICU NURSE REPORTED ALARMS FOR HIGH PURGE PRESSURE/PURGE SYSTEM BLOCKED. BASED ON THE INFORMATION PROVIDED, THIS CASE INVOLVES A SERIOUS PATIENT INJURY (HEMOLYSIS) AND DEATH IN A CRITICALLY ILL PATIENT WITH POSTCARDIOTOMY CARDIOGENIC SHOCK (PCCS) REQUIRING BIVENTRICULAR MECHANICAL CIRCULATORY SUPPORT. THE HIGH PURGE PRESSURE ALARMS OCCURRED FOLLOWING A PURGE CASSETTE EXCHANGE AND RESOLVED SPONTANEOUSLY WITHOUT DEVICE REPLACEMENT OR TPA ADMINISTRATION. NO DEFINITIVE DEVICE MALFUNCTION WAS IDENTIFIED, AND THE CONTRIBUTION OF THE IMPELLA DEVICES TO THE PATIENT¿S HEMOLYSIS AND SUBSEQUENT DEATH CANNOT BE RULED OUT. THE IMPELLA PUMPS WERE NOT AVAILABLE FOR PRODUCT RETURN; DEVICE INVOLVEMENT CANNOT BE FULLY ASSESSED WITHOUT PRODUCT EVALUATION AND DEVICE RETURN. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA RP FLEX BUT IS UNLIKELY RELATED AND IS MOST LIKELY ATTRIBUTED TO PATIENTS MULTIPLE UNDERLYING CRITICAL CONDITIONS AS THEY PRESENTED IN SCAI STAGE D SHOCK ON MULTIPLE INOTROPES AND PRESSORS AND WAS VENTILATED FOR RESPIRATORY SUPPORT, AND HAS END STAGE RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920012 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026814355 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death