BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24756608 · Received April 1, 2026

    Report

    Report Number
    1220648-2026-06254
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 26, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    CLINICAL NARRATIVE: A 57-YEAR-OLD FEMALE WITH A HISTORY OF HYPERTENSION INITIALLY PRESENTED TO A LOCAL CLINIC WITH FEVER AND FATIGUE THAT PROGRESSIVELY WORSENED DESPITE SYMPTOMATIC TREATMENT. ON HOSPITAL DAY 3, SHE WAS REFERRED TO HOSPITAL A, WHERE LABORATORY EVALUATION DEMONSTRATED ELEVATED INFLAMMATORY AND MYOCARDIAL MARKERS (CRP 24 MG/DL, CREATININE 4.56 MG/DL, CREATINE KINASE 697 U/L, AND POSITIVE TROPONIN T). CORONARY ANGIOGRAPHY SHOWED NO SIGNIFICANT CORONARY ARTERY STENOSIS. SHE WAS DIAGNOSED WITH ACUTE MYOCARDITIS ACCOMPANIED BY ACUTE KIDNEY INJURY, AND AN ENDOMYOCARDIAL BIOPSY WAS PERFORMED FOLLOWED BY INTRA-AORTIC BALLOON PUMP (IABP) INSERTION AND INITIATION OF CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). ON HOSPITAL DAY 6, BIOPSY RESULTS CONFIRMED LYMPHOCYTIC FULMINANT MYOCARDITIS, AND METHYLPREDNISOLONE PULSE THERAPY WAS STARTED. ON THE SAME DAY, IABP SUPPORT WAS TRANSITIONED TO AN IMPELLA CP DEVICE. COMPLETE ATRIOVENTRICULAR BLOCK WAS OBSERVED, AND A TEMPORARY PACEMAKER WAS PLACED. DESPITE THESE INTERVENTIONS, HEMODYNAMICS DETERIORATED, AND VA-ECMO WAS INITIATED ON HOSPITAL DAY 9. THE PATIENT WAS TRANSFERRED TO THE REPORTING HOSPITAL ON HOSPITAL DAY 13. FOLLOWING TRANSFER, BLEEDING WAS OBSERVED AT CATHETER PUNCTURE SITES. THE IMPELLA PURGE SOLUTION WAS CHANGED FROM HEPARIN TO SODIUM BICARBONATE. THROMBOCYTOPENIA DEVELOPED, RAISING CONCERN FOR HEPARIN-INDUCED THROMBOCYTOPENIA (HIT), PROMPTING COMPLETE DISCONTINUATION OF HEPARIN. ANTICOAGULATION WAS TRANSITIONED TO NAFAMOSTAT MESYLATE AND ARGATROBAN. ECMO WAS DISCONTINUED ON DAY 14 AND THE TEMPORARY PACEMAKER REMOVED. THE IMPELLA CP WAS REMOVED ON DAY 15. ON DAY 17, HIT ANTIBODY TESTING RETURNED POSITIVE. CONTINUOUS HEMODIAFILTRATION WAS DISCONTINUED AND INTERMITTENT DIALYSIS INITIATED USING ARGATROBAN ANTICOAGULATION. THE PATIENT WAS DISCHARGED FROM THE ICU ON DAY 22. BY DAY 28, CARDIAC FUNCTION HAD FULLY RECOVERED; HOWEVER, ANURIA PERSISTED, AND INTERMITTENT DIALYSIS WITH ARGATROBAN WAS CONTINUED PRIOR TO TRANSFER BACK TO HOSPITAL A. THROUGHOUT THE ICU COURSE, THE PATIENT EXPERIENCED MILD RETROPERITONEAL HEMATOMA FORMATION, BLEEDING FROM ECMO SHEATH PUNCTURE SITES, AND ONGOING BLEEDING RISK IN THE CONTEXT OF MECHANICAL CIRCULATORY SUPPORT AND ANTICOAGULATION MANAGEMENT; HOWEVER, NO FATAL BLEEDING OR THROMBOTIC COMPLICATIONS OCCURRED. THE REPORTED MAJOR BLEED IS CONSISTENT WITH ANTICOAGULATION-ASSOCIATED AND ACCESS-SITE BLEEDING COMPLICATIONS COMMONLY ENCOUNTERED IN PATIENTS REQUIRING MECHANICAL CIRCULATORY SUPPORT (MCS), ECMO, AND RENAL REPLACEMENT THERAPY. THE REPORTED THROMBOCYTOPENIA IS CONSISTENT WITH HEPARIN-INDUCED THROMBOCYTOPENIA IN THE SETTING OF SYSTEMIC HEPARIN EXPOSURE, CRITICAL ILLNESS, AND PROLONGED EXTRACORPOREAL SUPPORT, NECESSITATING ALTERNATIVE ANTICOAGULATION STRATEGIES. THE REPORTED HEMATOMA IS CONSISTENT WITH ACCESS-SITE AND RETROPERITONEAL BLEEDING RELATED TO MULTIPLE VASCULAR CANNULATIONS, ANTICOAGULATION EXPOSURE, AND CRITICAL ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813841 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown Required Intervention