BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 21938452 · Received April 30, 2025

    Report

    Report Number
    1220648-2025-27978
    Event Type
    Death
    Date Received
    April 30, 2025
    Date of Event
    April 17, 2025
    Report Date
    July 11, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502013054
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B1-ADVERSE EVENT B2-SELECTED DEATH AND ADDED DATE OF DEATH. B5-ADDITIONAL DETAILS PROVIDED STATES THAT THE PATIENT EXPIRED WHILE ON SUPPORT. H6-CLINICAL CODE 4580, IMPACT CODE 1802. H10-MEDICAL SAFETY OFFICER (MSO) REVIEW. THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE,¿AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED. THE INSTRUCTIONS FOR USE FOR THE IMPELLA 5.5 WITH SMART ASSIST FOR USE DURING CARDIOGENIC SHOCK STATES THE FOLLOWING: SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES): ¿ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION).¿ IT WAS FURTHER REPORTED THAT CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. THE PATIENT'S OUTCOME WAS REVIEWED BY ABIOMED'S MEDICAL SAFETY OFFICER (MSO) AND ALTHOUGH THE CAUSE OF DEATH IS PROVIDED AND NOTED AS MULTIPLE ORGAN FAILURE (MOF), IT CANNOT BE SAID THAT THE LOSS/LACK OF HEMODYNAMIC SUPPORT HAD NOTHING TO DO WITH THE FINAL OUTCOME. THERE IS NOT ENOUGH EVIDENCE TO EXCLUDED THE IMPELLA AS AN ASSOCIATED FACTOR TO THE OUTCOME. H1-UPDATED TO DEATH.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF POSITIONING ISSUES HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. CLINICAL STATES THAT THE PUMP WAS PULLED OUT INTO VENTRICLE WHEN THE PATIENT WAS CHANGING POSITION FOR AN X-RAY. PUMP WAS EXPLANTED AND REPLACED WITH ANOTHER PUMP. AS PER THE CLINICAL INFORMATION PROVIDED, THE ROOT CAUSE OF THE POSITIONING ISSUE WAS MOST LIKELY USE RELATED DUE TO IMPROPER TECHNIQUE. B1 PRODUCT PROBLEM WAS INADVERTENTLY OMITTED ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27978-1. B3 DATE OF EVENT WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27978.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PATIENT EXPIRED ON SUPPORT.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A PATIENT HAD AN IMPELLA 5.5 PUMP PLACED FOR SUPPORT DURING A HIGH-RISK PROCEDURE. THE PUMP WAS SUPPORTING FOR SIX DAYS WHEN ACCIDENTALLY THE PUMP WAS PULLED OUT OF POSITION. THE PUMP WAS NOT RE-DELIVERED ACROSS THE VALVE TO THE LEFT VENTRICLE SO THE PUMP WAS EXPLANTED AND REPLACED. FURTHER DETAILS WERE RECEIVED STATING THAT THE PATIENT EXPIRED DUE TO A CAUSE UNRELATED TO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181412 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5-JP 2025574182 00813502013054

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Death