BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24858441 · Received April 13, 2026

    Report

    Report Number
    1220648-2026-06693
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    April 5, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: OMITTED A150202, THE DEVICE WAS NOT MALPOSITIONED.

    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

    D4. CATALOG, SERIAL AND PRIMARY UDI NUMBER CORRECTED. H6: INVESTIGATION: TYPE, FINDINGS, CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION/ANALYSIS OF THE DEVICE WAS NOT POSSIBLE. THE CAUSE OF HEMOLYSIS WAS NOT DETERMINED DUE TO LACK OF CLINICAL DETAILS, NO PRODUCT OR DATA LOGS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    A 52 YEAR OLD FEMALE WITH A PRE SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE D AND A MEDICAL HISTORY SIGNIFICANT FOR CARDIOMYOPATHY, DIABETES MELLITUS, AND RENAL INSUFFICIENCY REQUIRING DIALYSIS UNDERWENT IMPELLA 5.5 SUPPORT VIA RIGHT AXILLARY/SUBCLAVIAN SURGICAL ARTERIAL ACCESS. THE DEVICE WAS IMPLANTED ON (B)(6) 2026 AT 18:25 AND EXPLANTED ON (B)(6) 2026 AT 16:30. DURING IMPELLA SUPPORT, THE PATIENT WAS ALSO RECEIVING VA ECMO. HEMOLYSIS WAS IDENTIFIED DURING SUPPORT BASED ON ELEVATED PLASMA FREE HEMOGLOBIN, WITH TWO PLASMA FREE HEMOGLOBIN RESULTS EXCEEDING 40 MG/DL WITHIN 24 HOURS. THE DEVICE WAS SUBSEQUENTLY REPOSITIONED TO 4.5 CM, WHICH RESOLVED THE POSITIONING ISSUE. THE ECMO CIRCUIT WAS ALSO EXCHANGED DURING THIS TIME. HEMOLYSIS DID NOT RESOLVE WITH IMPELLA REMOVAL. NO BLOOD PRODUCTS WERE ADMINISTERED, AND NO ORGAN DAMAGE WAS REPORTED. THE PATIENT INJURY WAS CLASSIFIED AS HEMOLYSIS, WITH OTHER CONTRIBUTING FACTORS INCLUDING VA ECMO SUPPORT. BASED ON THE AVAILABLE INFORMATION, HEMOLYSIS OCCURRED DURING IMPELLA SUPPORT IN A PATIENT RECEIVING CONCURRENT VA ECMO; HOWEVER, DEVICE MALFUNCTION WAS NOT CONFIRMED, THE DEVICE REMAINED IN APPROPRIATE POSITION FOLLOWING REPOSITIONING, AND THE RELATIONSHIP BETWEEN THE REPORTED HEMOLYSIS AND THE IMPELLA DEVICE COULD NOT BE DETERMINED. THE IMPELLA WAS SUCCESSFULLY WEANED AND THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613407 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026781172 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1