BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24415649 · Received February 23, 2026

    Report

    Report Number
    1220648-2026-03813
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    October 10, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THROMBOSIS: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. LOW OR BLOCKED PUMP FLOW: THE ROOT CAUSE OF THE LOW PUMP FLOW WAS MOST LIKELY BIOMATERIAL INGESTION BASED ON PROVIDED CLINICAL DETAILS AND DATA LOG ANALYSIS.

    Description of Event or Problem · 0

    A 75-YEAR-OLD MALE UNDERGOING POST-OPERATIVE CT SURGERY SUPPORT REMAINED IN SCAI SHOCK STAGE C AT THE TIME OF INITIAL MECHANICAL CIRCULATORY SUPPORT. THIS EVENT IS A CONTINUATION OF GU CASE (B)(4). THE PATIENT PREVIOUSLY HAD AN IMPELLA RP FLEX REMOVED DUE TO DEVICE FAILURE, AND A REPLACEMENT RP FLEX (S/N (B)(6)) WAS IMPLANTED ON (B)(6) 2025. ANTICOAGULATION THERAPY WAS HELD FOR FOUR DAYS PRIOR TO THE EVENT, DESPITE DAILY COUNSELING REGARDING THE INCREASED RISK OF THROMBOSIS WHILE ON RP SUPPORT. CARDIOTHORACIC SURGERY AND CARDIOLOGY TEAMS WERE AWARE AND DECLINED REINSTATING ANTICOAGULATION. ON (B)(6) 2026, THE RP FLEX DEMONSTRATED SIGNS OF THROMBUS INGESTION ASSOCIATED WITH LOW PUMP FLOW. THE PATIENT WAS BROUGHT TO THE CCL WHERE THE DEVICE WAS EXPLANTED. THE PATIENT WAS HEMODYNAMICALLY STABLE, NO LONGER REQUIRED IMPELLA SUPPORT, AND NO PATIENT HARM OCCURRED. THE PUMP WAS REMOVED AND DISCARDED. NO DEVICE RETURN WAS INITIALLY EXPECTED, BUT PRODUCT RETURN IS NOW INDICATED FOR DATA DOWNLOAD. THE PATIENT SURVIVED TO EXPLANT, WAS SUCCESSFULLY WEANED, AND EXPERIENCED NO ADVERSE CLINICAL OUTCOME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES THAT BOTH RP FLEX PUMPS, SERIAL NUMBERS (B)(6), EXPERIENCED CLOT INGESTION. RP FLEX (S/N (B)(6)), WHICH WAS PUMP #2 OF 3, WAS REMOVED DUE TO CLOT INGESTION AFTER THE SWAN-GANZ CATHETER WAS NOTED TO BE NONFUNCTIONAL AND SUBSEQUENTLY REMOVED; DURING REMOVAL, A CLOT WAS INGESTED INTO THE PUMP. THE PATIENT WAS NOT ON HEPARIN FOR THE DURATION OF PUMP SUPPORT PER PHYSICIAN DECISION. FOLLOWING REMOVAL OF PUMP #2, PUMP #3 WAS PLACED. THERE WAS NO FOURTH PUMP INVOLVED; PUMP #3 WAS LATER REMOVED AFTER RIGHT VENTRICULAR RECOVERY. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365581 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 RP FLEX W SMART ASSIST SET, US 2026741965 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention