BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA RP

    MDR report key: 23306664 · Received October 15, 2025

    Report

    Report Number
    1220648-2025-47528
    Event Type
    Death
    Date Received
    October 15, 2025
    Date of Event
    August 12, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    04260113630273
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT INVESTIGATION CLOSURE. INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED. CARDIAC ARREST, PERICARDIAL EFFUSION: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE IN WRONG POSITION (POSITIONING ISSUE): THE CAUSE OF THE POSITIONING ISSUE WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PUMP SUCTION: PATIENT HAD SUCTION ALARMS. NO LOGS ARE AVAILABLE FOR REVIEW. THE CAUSE OF PUMP SUCTION CANNOT BE DETERMINED SINCE INSUFFICIENT CLINICAL DETAILS WERE PROVIDED. DEVICE HISTORY LOT: DEVICE LOT: 1811679. DEVICE HISTORY REVIEW: DEVICE (SN: (B)(6)) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    GIVEN THE LIMITED INFORMATION SURROUNDING THE DETAILS THE PATIENT'S CONDITION AND CAUSE OF DEATH THE IMPELLA RP CANNOT BE EXCLUDED AS A POSSIBLE CONTRIBUTING FACTOR. A.4 IS UNKNOWN. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP AND IMPELLA RP DEVICES FOR MECHANICAL CIRCULATORY SUPPORT FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PCI IT WAS REPORTED THAT THE IMPELLA RP WAS NOT POSITIONED OPTIMALLY. THE PHYSICIAN ATTEMPTED TO ADVANCE THE RP, BUT THE PIGTAIL ON THE IMPELLA RP DID NOT MOVE FORWARD. AFTER THE PCI WAS COMPLETED, AND PRIOR TO BEING RELEASED TO THE CARDIAC CARE UNIT (CCU), PERICARDIAL EFFUSION WAS DISCOVERED WITH AN ECHOCARDIOGRAM. A DRAIN WAS PLACED FOR THE PERICARDIAL FLUID. IT WAS THEN NOTED THAT SUCTION ALARMS OCCURRED ON BOTH DEVICES AND POSITION WAS REVIEWED AND NO IMPELLA POSITION ADJUSTMENTS WERE NEEDED. THE SOURCE OF THE BLEED COULD NOT BE DETERMINED WITH ECHOCARDIOGRAM OR ANGIOGRAM. THE PATIENT DETERIORATED AND WENT INTO PULSELESS ELECTRICAL ACTIVITY. THE PATIENT EXPIRED UPON ARRIVAL TO THE CCU. THE PHYSICIAN WHO WAS THE HEAD OF THE MEDICAL TEAM STATED HE DID NOT BELIEVE THE CAUSE OF THE PERICARDIAL EFFUSION TO BE RELATED TO THE IMPELLA RP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2744133 IMPELLA RP TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP 2025480905 04260113630273

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death