BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP

    MDR report key: 25067507 · Received May 4, 2026

    Report

    Report Number
    1220648-2026-07383
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 26, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    04260113630273
    PMA / PMN Number
    P170011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS SOLVED AND THE PATIENT RECOVERED. THE PUMP WAS EXPLANTED, BUT UNFORTUNATELY THROWN AWAY, SO IT IS NOT AVAILABLE FOR RETURN. THE DEVICE WAS NOT REMOVED BECAUSE OF THE COMPLAINT. 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 RP DEVICE WAS INSERTED VIA THE LEFT FEMORAL VEIN IN A 31-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE E. DURING SUPPORT, THE REGISTERED NURSE OBSERVED DECREASING PURGE FLOW FROM 5.5 ML/H AND PURGE PRESSURE OF 584 MMHG IN THE MORNING TO 2.9 ML/H AND PURGE PRESSURE OF 860 MMHG LATER IN THE DAY. THERE WAS NO INCREASE IN MOTOR CURRENT, NO ALARMS, AND THE PUMP WAS FUNCTIONING WELL. THE LAST PARTIAL THROMBOPLASTIN TIME (PTT) WAS 41 SECONDS, AND THE HEPARIN DOSE HAD ALREADY BEEN INCREASED. THE CASE WAS DISCUSSED AND RECOMMENDATIONS WERE GIVEN, INCLUDING POINTING OUT RISKS AND WHAT TO OBSERVE. THE TEAM WANTED TO INITIATE TPA-PURGE-LYSIS, AND THE PROTOCOL WAS SENT VIA EMAIL. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS UTILIZED FOR HIGH PURGE PRESSURE TO MITIGATE THE IMPACT OF BIOMATERIAL WITHIN THE MOTOR, AND THERE WAS NO IMPACT ON THE PATIENT. THE PATIENT SURVIVED TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593855 TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026815316 04260113630273

    Patients

    Seq Age Sex Outcome Treatment
    1