BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP

    MDR report key: 25242472 · Received May 21, 2026

    Report

    Report Number
    1220648-2026-08081
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    May 17, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    04260113630273
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 PRIMARY UDI NUMBER WAS REVISED AS IT WAS PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL REPORT THAT WAS SUBMITTED. D9 DEVICE WAS RETURNED AND DATE RECEIVED WAS ADDED. H6 TYPE OF INVESTIGATION CODE WAS UPDATED DUE TO THE DEVICE BEING RETURNED. H11 UPDATED ADDITIONAL MANUFACTURER NARRATIVE DUE TO DEVICE BEING RETURNED. THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL REPORT WILL BE FILED.

    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: IMPELLA RP WAS INSERTED VIA THE RIGHT FEMORAL VEIN IN A 64 YEAR-OLD MALE PATIENT PRESENTING WITH RIGHT HEART FAILURE FOLLOWING MITRAL VALVE REPLACEMENT IN THE SETTING OF POST-CARDIOTOMY CARDIOGENIC SHOCK. THE PATIENT¿S CLINICAL CONDITION WAS FURTHER COMPLICATED BY A DILATED RIGHT VENTRICLE AND HIGHLY COMPROMISED EJECTION FRACTION. THE PATIENT HAD KNOWN PULMONARY HYPERTENSION. PRIOR TO IMPELLA RP INSERTION, THE PATIENT WAS SUPPORTED WITH VENO-ARTERIAL EXTRACORPOREAL LIFE SUPPORT, WITH EXTRACORPOREAL LIFE SUPPORT SERVING AS THE PRIMARY HEMODYNAMIC SUPPORT DEVICE AND THE IMPELLA DEVICE UTILIZED FOR LEFT VENTRICULAR VENTING. FOLLOWING INITIATION OF IMPELLA RP SUPPORT, THE DEVICE WAS GRADUALLY RAMPED UP WHILE VENO-ARTERIAL EXTRACORPOREAL LIFE SUPPORT FLOW WAS CONCURRENTLY REDUCED. APPROXIMATELY 25 TO 30 MINUTES AFTER INITIATION OF SUPPORT, BLOODY FLUID WAS OBSERVED IN THE ENDOTRACHEAL TUBE, AND OXYGENATION ISSUES WERE NOTED. IN RESPONSE, IMPELLA RP SUPPORT WAS REDUCED TO PERFORMANCE LEVEL 2 TO FURTHER ASSESS THE PATIENT¿S CONDITION. DUE TO ONGOING CONCERNS, THE DECISION WAS MADE TO EXPLANT THE IMPELLA RP DEVICE AND TRANSITION THE PATIENT FROM VENO-ARTERIAL EXTRACORPOREAL LIFE SUPPORT TO VENO-ARTERIAL-VENOUS EXTRACORPOREAL LIFE SUPPORT FOR CONTINUED SUPPORT. THE HEALTHCARE PROVIDER INTERPRETED THE PULMONARY EDEMA OBSERVED AS "A TYPICAL COMPLICATION" OF RIGHT-SIDED MECHANICAL CIRCULATORY SUPPORT IN THE CONTEXT OF UNDERLYING PULMONARY HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100485 TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2027836406 04260113630273

    Patients

    Seq Age Sex Outcome Treatment
    1