BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 23044421 · Received September 12, 2025

    Report

    Report Number
    1220648-2025-46428
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 14, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY. PUMP SN (B)(6) AND PURGE CASSETTE RETURNED. UNABLE TO DELIVER OR ADVANCE: NO ISSUES WERE FOUND WITH THE RETURNED PRODUCT. THE CAUSE OF THE DELIVERY ISSUE WAS DETERMINED TO BE PATIENT CONDITION AS THE PATIENT HAD SEVERE CALCIFIED AXILLARY ARTERY PREVENTING SUCCESSFUL DELIVERY OF IMPELLA. DEVICE HISTORY LOT. DEVICE LOT: 1924526. DEVICE HISTORY BATCH. SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW. DEVICE (SN: (B)(6)) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    MEDICAL SAFETY REVIEWED THE EVENT. THE FIRST EVENT DESCRIBES AN ACUTE KIDNEY INJURY REQUIRING INTERVENTION AND WAS NOT BELIEVED TO BE DUE TO THE IMPELLA CP PUMP 1. THE ACUTE KIDNEY INJURY IS MOST LIKELY A RESULT OF THE PATIENT CONDITION, AND THE IMPELLA DEVICE WAS UNLIKELY A CONTRIBUTING FACTOR. THE PATIENT HAD POOR EJECTION FRACTION (10%) LOW CARDIAC OUTPUT STATE REQUIRING IMPELLA SUPPORT. THE PATIENT WAS CRITICALLY ILL AND POSSIBLE DELAY IN CONSIDERING ESCALATION TO THE IMPELLA 5.5. WITH THIS INFORMATION ALONE, IT IS VERY UNLIKELY THE IMPELLA DEVICE CAUSED THE ACUTE KIDNEY INJURY. HOWEVER, IT CANNOT BE EXCLUDED BASED ON THE INFORMATION AT HAND AND IS A SERIOUS INJURY. THE IMPELLA 5.5 INABILITY TO BE INSERTED DUE TO CALCIFICATION IN THE AXILLARY ARTERY SHOULD BE REPORTED AS A MALFUNCTION TYPE OF REPORTABLE EVENT. THE PATIENT WAS THEREFORE PLACED ON ANOTHER IMPELLA CP VIA THE RIGHT FEMORAL ARTERY AFTER FAILURE TO DELIVERY THROUGH THE AXILLARY ARTERY AND ECMO. THE DEVICES NOT BEING ABLE TO BE INSERTED THROUGH THE AXILLARY ARTERY ARE ALSO MOST LIKELY THE RESULT OF THE NOTED PATIENTS PREEXISTING CALCIFICATION WHICH IS A CONTRAINDICATION TO INSERTION. AFTER APPROXIMATELY 9 DAYS ON ECPELLA THE PATIENT'S CARE WAS WITHDRAWN. THERE IS NOT ENOUGH INFORMATION TO DISSOCIATE THE DEMISE OUT FROM THE IMPELLA CP DEVICE PUMP 3. CAUSE OF DEATH IS UNKNOWN. HOWEVER, ALTHOUGH THIS DISSOCIATION CANNOT BE MADE, DUE TO THE DURATION OF SUPPORT AND THE FACT THAT CARE WAS ELECTIVELY WITHDRAWN, IT IS UNLIKELY THAT CP (PUMP 3) WAS ASSOCIATED TO THE PATIENTS CAUSE OF DEATH. THE PATIENT'S UNDERLYING CONDITION LIKELY CONTRIBUTED MOST TO AN OUTCOME OF DEATH. RELATED MEDICAL DEVICE REPORTS: THIS IMPELLA 5.5 DEVICE REPORT IS ONE OF THREE DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICES REPORTS FOR THE OTHER TWO IMPELLA DEVICES IN WHICH ONE IS ASSOCIATED WITH THE DEMISE OUTCOME.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. ON THE SECOND DAY OF SUPPORT, THE PATIENT WAS NOTED TO HAVE AN ACUTE KIDNEY INJURY (AKI). CONTINUOUS RENAL REPLACEMENT THERAPY WAS INITIATED DUE TO THE AKI. THE PHYSICIAN STATED THAT THEY DID NOT BELIEVE THE IMPELLA WAS THE CAUSE OF THE AKI. THE SAME DAY, THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO BE ESCALATED TO AN IMPELLA 5.5 FOR INCREASED HEMODYNAMIC SUPPORT. DURING THE IMPELLA 5.5 IMPLANT, THE PHYSICIAN WAS UNABLE TO ADVANCE THE IMPELLA AND DELIVER TO THE LEFT VENTRICLE DUE TO CALCIFICATION IN THE AXILLARY ARTERY. THE IMPELLA 5.5 WAS ABORTED, AND THE IMPELLA CP WAS ATTEMPTED IN THE SAME AXILLARY ARTERY ACCESS. THE IMPELLA CP WAS ALSO UNSUCCESSFULLY DELIVERED TO THE LEFT VENTRICLE, AND THE AXILLARY ARTERY ACCESS WAS ABORTED. THE IMPELLA CP WAS THEN PLACED SUCCESSFULLY INTO THE RIGHT FEMORAL ARTERY, SUPPORT WAS INITIATED, AND THE PATIENT WAS TAKEN BACK TO THEIR HOSPITAL ROOM TO RECOVER. ADDITIONALLY, THE SAME DAY, THE PATIENT WAS CANNULATED FOR VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE PATIENT CONTINUED IMPELLA CP SUPPORT, HOWEVER IT WAS NOTED THAT ON (B)(6) 2025 SUPPORT WAS WITHDRAWN. STATUS OF IMPELLA SUPPORT AND PATIENT IS UNKNOWN AT THIS TIME. THIS COMPLAINT INVOLVES THREE IMPELLA DEVICES: PUMP 1: IMPELLA CP WITH SERIAL NUMBER (B)(6). PUMP 2: IMPELLA 5.5 WITH SERIAL NUMBER (B)(6). PUMP 3: IMPELLA CP WITH SERIAL NUMBER (B)(6). THIS MDR SPECIFICALLY ADDRESSES IMPELLA 5.5 WITH SERIAL NUMBER (B)(6), WHICH IS THE SUBJECT OF THIS REPORT. SEPARATE MDRS WILL BE SUBMITTED FOR THE OTHER DEVICES ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2655116 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026675680 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male