BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24546021 · Received March 9, 2026

    Report

    Report Number
    1220648-2026-04769
    Event Type
    Death
    Date Received
    March 9, 2026
    Date of Event
    March 2, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D3 (MANUFACTURER FAX) AND G1 (MANUFACTURER CONTACT FAX NUMBER) HAS BEEN ADDED AS THIS WAS OMITTED FROM THE INITIAL MW SUBMITTED. D4 (PRIMARY UDI NUMBER) HAS BEEN UPDATED. 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

    THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENTS THE IMPELLA 5.5 AND ANOTHER REPORT WILL BE SUBMITTED TO REPRESENT THE IMPELLA CP. 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 AND D4. PERICARDIAL EFFUSION: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. ASAE /MAJOR BLEED: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA 5.5 WAS SURGICALLY IMPLANTED VIA THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 67-YEAR-OLD MALE PATIENT WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK (AMI/CGS), PRESENTING IN SCAI STAGE E SHOCK. DURING INTRA PROCEDURAL CARE, A PERICARDIAL EFFUSION WAS IDENTIFIED AND A PERICARDIAL DRAIN WAS PLACED. A DRAIN WAS ALSO POSITIONED IN THE RIGHT AXILLARY IMPELLA POCKET. SIGNIFICANT PROCEDURAL BLEEDING WAS REPORTED, REQUIRING TRANSFUSION OF 4 UNITS PACKED RED BLOOD CELLS (PRBCS), 2 UNITS FRESH FROZEN PLASMA (FFP), AND 1 UNIT PLATELETS. THE INTRODUCER HAD BEEN PEELED AWAY OUTSIDE THE BODY, AND HEMOSTASIS WAS ACHIEVED THROUGH DRAINAGE RATHER THAN STANDARD MANUAL OR SUTURE BASED TECHNIQUES. THE PRECISE LOCATION OF BLEEDING WAS UNDOCUMENTED, AND CONTRIBUTING CLINICAL FACTORS¿INCLUDING ANTICOAGULATION REGIMEN, PATIENT COMORBIDITIES, OR PROCEDURAL FACTORS¿WERE NOT IDENTIFIED. THE IMPELLA REMAINED IN PLACE, WAS NOT REMOVED DUE TO THE EVENT, AND PRODUCT RETURN WAS REQUESTED FOR BOTH THE PUMP AND INTRODUCER. THE PATIENT ULTIMATELY CONTINUED TO DECLINE, AND CARE WAS WITHDRAWN, RESULTING IN DEATH WHILE ON SUPPORT. BASED ON AVAILABLE INFORMATION, THE REPORTED BLEEDING CONSTITUTES AN ACCESS SITE¿RELATED CLINICAL COMPLICATION, BUT THERE IS NO EVIDENCE THAT THE IMPELLA 5.5 MALFUNCTIONED OR DIRECTLY CAUSED THE PATIENT¿S DETERIORATION OR DEATH. THE PATIENT¿S DECLINE APPEARS MORE CONSISTENT WITH SEVERE UNDERLYING CARDIOGENIC SHOCK AND INTRA PROCEDURAL BLEEDING RATHER THAN DEVICE PERFORMANCE FAILURE. FINAL ASSESSMENT REMAINS PENDING PRODUCT ANALYSIS. THE DEATH IS CONSERVATIVELY BEING REPORTED ON THE IMPELLA 5.5 BUT IS UNLIKELY A CONTRIBUTING FACTOR TO THE CAUSE OF DEATH AND IS MORE LIKELY DUE TO THE PATIENT¿S DECLINING CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557183 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026802415 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1