BEUDAMED
    FDA Adverse Event Death Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24079758 · Received January 15, 2026

    Report

    Report Number
    1220648-2026-00814
    Event Type
    Death
    Date Received
    January 15, 2026
    Date of Event
    December 18, 2025
    Report Date
    January 27, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL SAFETY/CLINICAL REVIEWED THE EVENT. INDICATION FOR USE WAS PULMONARY EMBOLISM AND AT INITIATION OF SUPPORT PATIENT WAS SCAI STAGE E. THERAPIES USED BEFORE MECHANICAL SUPPORT INOTROPES/VASOPRESSORS (=3 AGENTS) AND RESPIRATORY SUPPORT. THE PATIENT WAS INITIALLY NOTED AS A ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) WITH CARDIOGENIC SHOCK, AND PLACEMENT OF AN IMPELLA CP WAS REQUESTED. HOWEVER, UPON FURTHER EVALUATION, THE PATIENT'S PRESENTATION WAS CONSISTENT WITH A MASSIVE PULMONARY EMBOLISM. THE TREATMENT WAS REVISED TO INCLUDE THROMBECTOMY AND IMPLANTATION OF AN IMPELLA RP FLEX DEVICE FOR RIGHT VENTRICULAR MECHANICAL CIRCULATORY SUPPORT. AFTER INITIATION OF IMPELLA RP FLEX SUPPORT, NURSING STAFF REPORTED EVIDENCE OF HEMOLYSIS, AND LABS WERE NOTED TO BE HEMOLYZED. PULMONARY ARTERY PRESSURES REMAINED ELEVATED AT APPROXIMATELY 63/52 MMHG. AT A SUPPORT LEVEL OF P-7, THE IMPELLA RP FLEX FLOW WAS APPROXIMATELY 2.3 L/MIN, WHICH WAS CONSIDERED LOW PUMP FLOW. THE PATIENT¿S PLATELET COUNT DECLINED, PROMPTING DISCONTINUATION OF SYSTEMIC HEPARIN THERAPY. DESPITE CONTINUED MECHANICAL CIRCULATORY SUPPORT, THE PATIENT¿S CLINICAL CONDITION PROGRESSIVELY WORSENED. APPROXIMATELY 11 HOURS AFTER INITIATION OF IMPELLA RP FLEX SUPPORT, THE PATIENT EXPIRED. NO FURTHER PROCEDURAL DETAILS OR DEVICE PERFORMANCE INFORMATION WERE AVAILABLE. THE PATIENT'S UNDERLYING CONDITION CONTRIBUTED MOST TO THE DEMISE OUTCOME (RIGHT VENTRICULAR FAILURE SECONDARY TO MASSIVE PULMONARY EMBOLISM), PERSISTENTLY ELEVATED PULMONARY ARTERY PRESSURES RESULTING IN LOW DEVICE FLOW, ONGOING CARDIOGENIC SHOCK (SCAI STAGE E), HEMOLYSIS. THE PATIENT WAS HEMODYNAMIC UNSTABLE DESPITE INOTROPES/VASOPRESSORS AND MECHANICAL SUPPORT. NOTE: H6. INVESTIGATION TYPE/FINDINGS/CONCLUSION REMAIN UNCHANGED AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 0

    B2: REQUIRED INTERVENTION SHOULD NOT HAVE BEEN SELECTED ON THE INITIAL REPORT THAT WAS SUBMITTED. G1: MANUFACTURING SITE NAME SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL REPORT THAT WAS SUBMITTED. H6: MEDICAL DEVICE PROBLEM CODE WAS ADDED AS IT WAS NOT PREVIOUSLY ON ANY SUBMITTED REPORTS.

    Additional Manufacturer Narrative · 0

    B5 UPDATED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS AND COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. INVESTIGATION SUMMARY: THE INVESTIGATION HAS BEEN COMPLETED. NO PRODUCT RETURN. LOW OR BLOCKED PUMP FLOW/HEMOLYSIS/MECAHNICAL INTERACTION WITH BLOOD: CLINICAL INFORMATION REPORTED HEMOLYZED LABS WITH FLOWS OF 2.3 LITERS PER MINUTE (LPM) AT P7. THE LOGS SHOW 2 MOTOR CURRENT SPIKES WITH SPEED DEVIATIONS AND PLACEMENT SIGNAL SHIFTS CHARACTERISTIC OF BIOMATERIAL INGESTION. THE FIRST INGESTION OCCURRED AT 15:45PM WHILE PUMP WAS AT P6 FLOWING AT APPROPRIATE RANGE (2.0 - 3.0 LPM) AFTER WHICH FLOW DECREASED OUTSIDE EXPECTED RANGE. THE SECOND INGESTION EVENT WAS AT 21:45PM WHILE PUMP WAS FLOWING AT P7. FLOWS WERE AT ABOUT 2.4 LPM AS A RESULT OF FIRST INGESTION EVENT BUT FURTHER DROPPED BELOW 2.0 LPM. MOTOR CURRENT DECREASED TILL PUMP EXPLANT WHILE FLOWS INCREASED SLIGHTLY BUT DID NOT RECOVER BEFORE EXPLANT. THE FIRST INGESTION EVENT OCCURRED BEFORE HEMOLYZED LABS WERE REPORTED AND SECOND EVENT LIKELY EXACERBATED IT. THE CAUSE OF THE LOW PUMP FLOW AND HEMOLYSIS ISSUES WERE ESTABLISHED TO BE BIOMATERIAL INGESTION AS EVIDENCED BY LOG ANALYSIS SHOWING MOTOR CURRENT SPIKES DEVICE HISTORY REVIEW: THE PUMP PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    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 HAS PROVIDED ADDITIONAL INFORMATION: "THE RP IS NOT AVAILABLE. ORIGINALLY PATIENT WAS CALLED A STEMI WITH CGS AND PHYSICIAN ASKED FOR A CP BUT THEN PATIENT DISPLAYED PE SYMPTOMS AND ULTIMATELY SWITCHED TO THROMBECTOMY AND RP FLEX".

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WITH AN IMPELLA RP FLEX EXPERIENCED HEMOLYSIS DURING SUPPORT. IT WAS REPORTED THAT ON THE FIRST DAY OF SUPPORT, THE PATIENT¿S LABORATORY SAMPLES WERE HEMOLYZED, AND THE PATIENT¿S PULMONARY ARTERY PRESSURES WERE REPORTED AS ELEVATED ON THE IMPELLA DEVICE. IT WAS NOTED THAT THE PERFORMANCE LEVEL OF THE IMPELLA RP FLEX WAS 7, FLOWS WERE 2.3 L/MIN, AND PULMONARY ARTERY PRESSURES WERE (57)63/52 MMHG. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT¿S PLATELETS HAD DECREASED AND SUBSEQUENTLY, SYSTEMIC HEPARIN WAS WITHHELD. IT WAS ADDITIONALLY NOTED THAT THE PATIENT¿S OUTCOME AT EXPLANT WAS EXPIRED. ADDITIONAL CLINICAL DETAILS, INCLUDING PERIOPERATIVE COURSE, CONTRIBUTING FACTORS, AND CAUSE OF DEATH, WERE UNAVAILABLE AT THE TIME OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145865 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2025575381 813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| D