BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24555604 · Received March 10, 2026

    Report

    Report Number
    1220648-2026-04852
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    November 3, 2025
    Report Date
    April 27, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA. D1 BRAND NAME UPDATED/CORRECTED. INVESTIGATION SUMMARY. ANEMIA/THROMBOCYTOPENIA: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PLACEMENT SIGNAL ISSUE: NO LOGS ARE AVAILABLE. THE CAUSE OF THE PLACEMENT SIGNAL ISSUE CANNOT BE DETERMINED SINCE NO LOGS ARE AVAILABLE AND INSUFFICIENT CLINICAL DETAILS WERE PROVIDED.

    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.

    Description of Event or Problem · 0

    69-YEAR-OLD FEMALE WITH A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, TYPE 2 DIABETES MELLITUS, AND END-STAGE RENAL DISEASE ON HEMODIALYSIS. UNDERWENT LEFT HEART CATHETERIZATION AS PART OF RENAL TRANSPLANT EVALUATION AND WAS FOUND TO HAVE MULTIVESSEL CORONARY ARTERY DISEASE. SHE WAS REFERRED TO CARDIAC SURGERY FOR CORONARY ARTERY BYPASS GRAFTING (CABG) AND MITRAL VALVE REPLACEMENT (MVR). ON POST-OPERATIVE DAY (POD) 3 AFTER CABG/MVR, THE PATIENT DEVELOPED RIGHT VENTRICULAR (RV) SHOCK AND WAS TAKEN TO THE CARDIAC CATHETERIZATION LABORATORY. SHE UNDERWENT SUCCESSFUL IMPELLA RP FLEX IMPLANTATION FOR RIGHT-SIDED MECHANICAL CIRCULATORY SUPPORT. DUE TO THROMBOCYTOPENIA, SYSTEMIC ANTICOAGULATION WAS NOT INITIATED. POST-IMPLANT, SHE REMAINED ON INTRAVENOUS INOTROPES AND VASOPRESSORS, AND CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WAS STARTED. THE IMPELLA RP PLACEMENT SENSOR WAS NONFUNCTIONAL; THE CLINICAL TEAM WAS INSTRUCTED TO TREND MOTOR CURRENT FOR PUMP ASSESSMENT AND TO CLINICALLY MONITOR USING APPROVED DIAGNOSTIC MODALITIES. DURING IMPELLA SUPPORT, THE PATIENT RECEIVED 2 UNITS OF PLATELETS AND 1 UNIT OF PACKED RED BLOOD CELLS FOR ONGOING THROMBOCYTOPENIA AND ANEMIA. SHE REMAINED OFF SYSTEMIC ANTICOAGULATION, WITH SODIUM BICARBONATE USED IN THE PURGE. ON DAY 8 OF IMPELLA RP FLEX SUPPORT (WITH ONGOING CRRT), THE PATIENT WAS HEMODYNAMICALLY LABILE AND EXPERIENCED ONE SUCTION EVENT, WHICH RESOLVED WITH ALBUMIN ADMINISTRATION. SHE REMAINED THROMBOCYTOPENIC; HIT (HEPARIN-INDUCED THROMBOCYTOPENIA) TESTING WAS NEGATIVE. SHE DEVELOPED LEUKOCYTOSIS WHILE ON CRRT. THE IMPELLA RP FLEX WAS SUCCESSFULLY WEANED AND EXPLANTED AFTER 14 DAYS OF SUPPORT. THE IMPELLA RP FLEX WILL BE CODED FOR PLACEMENT SIGNAL MALFUNCTION, AND CONSERVATIVELY CODED FOR ANEMIA AND THROMBOCYTOPENIA; HOWEVER, THE THROMBOCYTOPENIA WAS PRESENT PRIOR TO IMPELLA RP FLEX IMPLANTATION AND THE BLOOD TRANSFUSIONS WERE UNLIKELY TO BE RELATED TO THE DEVICE BUT RATHER DUE TO THE PATIENT'S UNDERLYING CRITICAL CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620525 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026666744 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention