BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24752983 · Received April 1, 2026

    Report

    Report Number
    1220648-2026-06218
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    August 10, 2023
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012453
    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

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN D3 AND G1. PPAE (THROMBOCYTOPENIA) : THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    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: AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE AXILLARY ARTERY IN A 33-YEAR-OLD FEMALE PATIENT PRESENTING WITH CARDIOMYOPATHY, SCAI SHOCK STAGE C. THE PATIENT'S COMORBIDITIES WERE UNKNOWN. THE PATIENT HAD PERIPARTUM CARDIOMYOPATHY AND WAS INITIALLY SUPPORTED WITH AN INTRA-AORTIC BALLOON PUMP (IABP) AT AN OUTSIDE HOSPITAL, WITH MINIMAL IMPROVEMENT IN CARDIAC FUNCTION. SHE WAS TRANSFERRED FOR ADVANCED HEART-FAILURE MANAGEMENT WITH CONSIDERATION FOR IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) THERAPY, AND IMPELLA 5.5 SUPPORT WAS INITIATED ON THE DAY OF TRANSFER. ON ARRIVAL, THE PATIENT¿S 4TS SCORE WAS 5, RAISING SUSPICION FOR HEPARIN-INDUCED THROMBOCYTOPENIA (HIT), AND IMMUNOLOGIC TESTING WAS PERFORMED. ON POSTOPERATIVE DAY (POD) 4, HIT-IGG ANTIBODIES WERE DETECTED AT 15.2 U/ML. ALL HEPARIN, INCLUDING HEPARIN IN THE IMPELLA PURGE SOLUTION, WAS DISCONTINUED, AND SYSTEMIC ANTICOAGULATION WITH ARGATROBAN WAS INITIATED AT 0.7 G/KG/MIN. SODIUM BICARBONATE PURGE SOLUTION COULD NOT BE USED. ARGATROBAN DOSING WAS TITRATED BASED ON COAGULATION PARAMETERS INCLUDING ACT, APTT, AND THROMBIN¿ANTITHROMBIN COMPLEX AND WAS SUBSEQUENTLY REDUCED TO 0.4 G/KG/MIN. FOLLOWING HEPARIN DISCONTINUATION, PLATELET COUNTS GRADUALLY IMPROVED, AND NO THROMBOEMBOLIC COMPLICATIONS WERE OBSERVED. REPEAT HIT IMMUNOLOGIC TESTING ON POD 26 REMAINED POSITIVE AT 4.5 U/ML. BECAUSE CARDIOPULMONARY BYPASS WITH ARGATROBAN (WITHOUT AN AVAILABLE ANTIDOTE) COMPLICATES COAGULATION MANAGEMENT, PLASMAPHERESIS WAS INITIATED TO REMOVE HIT ANTIBODIES PRIOR TO POTENTIAL IVAD IMPLANTATION. PLASMAPHERESIS WAS PERFORMED FOR THREE CONSECUTIVE DAYS, WITH SUBSEQUENT CONFIRMATION OF ANTIBODY NEGATIVITY BY IMMUNOLOGIC AND FUNCTIONAL TESTING. AS CARDIAC FUNCTION IMPROVED FOLLOWING PLASMA EXCHANGE, IVAD IMPLANTATION WAS DEEMED UNNECESSARY, AND IMPELLA 5.5 SUPPORT WAS DISCONTINUED ON POD 44. NO EVIDENCE OF PUMP THROMBOSIS OR HEMOLYSIS WAS OBSERVED DURING IMPELLA SUPPORT, AND NO THROMBUS WAS IDENTIFIED ON THE EXPLANTED CATHETER. THE PATIENT SURVIVED TO EXPLANT. THE REPORTED THROMBOCYTOPENIA IS CONSISTENT WITH HEPARIN-INDUCED THROMBOCYTOPENIA IN THE SETTING OF MECHANICAL CIRCULATORY SUPPORT, WITH PLATELET RECOVERY FOLLOWING CESSATION OF HEPARIN, INITIATION OF ALTERNATIVE ANTICOAGULATION, AND TARGETED PLASMAPHERESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623894 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2024289546 00813502012453

    Patients

    Seq Age Sex Outcome Treatment
    1