BEUDAMED
    FDA Adverse Event Death Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24632390 · Received March 18, 2026

    Report

    Report Number
    1220648-2026-05532
    Event Type
    Death
    Date Received
    March 18, 2026
    Date of Event
    November 7, 2025
    Report Date
    November 8, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN UPDATED EVENT DESCRIPTION HAS BEEN PROVIDED IN B5, AND NEW CODES WERE ADDED IN H6 (HEALTH EFFECT ¿ CLINICAL CODE) BASED ON THE NEW INFORMATION. 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.

    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.

    Additional Manufacturer Narrative · 0

    D4 (SERIAL) HAS BEEN UPDATED. ASAE/MINOR BLEED: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS USER RELATED AS THE BLEEDING WAS RESOLVED BY RETIED THE SUTURES TO MITIGATE THE OOZE WHEN COUGHING. RESPIRATORY FAILURE: RENAL FAILURE: CARDIOGENIC SHOCK: THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    UPDATED CLINICAL ASSESSMENT: 44-YEAR-OLD FEMALE WHOSE RELEVANT MEDICAL HISTORY: OBESITY, HYPERTENSION, ATRIAL FIBRILLATION, TOBACCO USE, CHRONIC HEART FAILURE WITH AN ACUTE PRESENTATION OF PULMONARY EMBOLISM WITH RIGHT VENTRICULAR (RV) CARDIOGENIC SHOCK. THE PATIENT PRESENTED WITH ACUTE PULMONARY EMBOLISM COMPLICATED BY PROFOUND RV FAILURE AND CARDIOGENIC SHOCK. DUE TO PERSISTENT HYPOTENSION, WORSENING PERFUSION, AND HEMODYNAMIC COLLAPSE RISK, THE HEART TEAM ELECTED TO SUPPORT HER WITH IMPELLA RP FLEX¿RECOGNIZING THAT USE FOR PULMONARY EMBOLISM IS OUTSIDE THE APPROVED INDICATION. DEVICE WAS INSERTED SUCCESSFULLY AND THE PATIENT TRANSPORTED TO ICU INTUBATED AND ON MULTIPLE VASOACTIVE AGENTS. HEMODYNAMICS ON ARRIVAL: CI 1.5 L/MIN/M², SVR 1624 DYNES/SEC/CM5. URINE OUTPUT SUBSEQUENTLY DIMINISHED, INDICATING WORSENING RENAL PERFUSION AND PERSISTENT CARDIOGENIC SHOCK. CONTINUED DEPENDENCE ON VASOPRESSORS AND INOTROPES. WHILE ON SUPPORT IT WAS NOTED THAT WHEN THE PATIENT COUGHED, VENTILATION RELATED, THERE WERE INTERMITTENT SUCTION ALARMS, THAT RESOLVED WHEN COUGHING SUBSIDED AND SOME OOZING AT THE ACCESS SITE. IT WAS REPORTED THAT THE NURSE DECREASED THE P-LEVEL TO STOP THE SUCTION ALARMS THEN RETURNED TO THE PREVIOUS P-LEVEL ONCE RESOLVED. THE MD RETIED THE SUTURES TO MITIGATE THE OOZE WHEN COUGHING. DESPITE CONTINUED SUPPORT THE CLINICAL CONDITION CONTINUED TO DETERIORATE AND THE PATIENT TRANSITIONED TO TO COMFORT-FOCUSED CARE. THE FAMILY ELECTED WITHDRAWAL OF CARE IN THE SETTING OF REFRACTORY SHOCK AND MULTI-ORGAN FAILURE. THE PATIENT EXPIRED FOLLOWING WITHDRAWAL OF LIFE-SUSTAINING TREATMENTS.

    Description of Event or Problem · 0

    44-YEAR-OLD FEMALE WHOSE RELEVANT MEDICAL HISTORY: OBESITY, HYPERTENSION, ATRIAL FIBRILLATION, TOBACCO USE, CHRONIC HEART FAILURE WITH AN ACUTE PRESENTATION OF PULMONARY EMBOLISM WITH RIGHT VENTRICULAR (RV) CARDIOGENIC SHOCK. THE PATIENT PRESENTED WITH ACUTE PULMONARY EMBOLISM COMPLICATED BY PROFOUND RV FAILURE AND CARDIOGENIC SHOCK. DUE TO PERSISTENT HYPOTENSION, WORSENING PERFUSION, AND HEMODYNAMIC COLLAPSE RISK, THE HEART TEAM ELECTED TO SUPPORT HER WITH IMPELLA RP FLEX¿RECOGNIZING THAT USE FOR PULMONARY EMBOLISM IS OUTSIDE THE APPROVED INDICATION. DEVICE WAS INSERTED SUCCESSFULLY AND THE PATIENT TRANSPORTED TO ICU INTUBATED AND ON MULTIPLE VASOACTIVE AGENTS. HEMODYNAMICS ON ARRIVAL: CI 1.5 L/MIN/M², SVR 1624 DYNES/SEC/CM5. URINE OUTPUT SUBSEQUENTLY DIMINISHED, INDICATING WORSENING RENAL PERFUSION AND PERSISTENT CARDIOGENIC SHOCK. CONTINUED DEPENDENCE ON VASOPRESSORS AND INOTROPES. NO DEVICE-RELATED COMPLICATIONS WERE DESCRIBED (NO ALARMS, NO MALPOSITION, NO PURGE ISSUES) HOWEVER THE CLINICAL CONDITION CONTINUED TO DETERIORAT AND THE PATIENT TRANSITIONED TO TO COMFORT-FOCUSED CARE. THE FAMILY ELECTED WITHDRAWAL OF CARE IN THE SETTING OF REFRACTORY SHOCK AND MULTI-ORGAN FAILURE. THE PATIENT EXPIRED FOLLOWING WITHDRAWAL OF LIFE-SUSTAINING TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430155 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2025599064 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1