BEUDAMED
    FDA Adverse Event Death Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24410347 · Received February 21, 2026

    Report

    Report Number
    1220648-2026-03725
    Event Type
    Death
    Date Received
    February 21, 2026
    Date of Event
    October 30, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE CAUSE OF THE HEMODYNAMIC INSTABILITY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE DEVICE IN WRONG POSITION WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE POOR VISUALIZATION WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1833601. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: DEVICE (SN: (B)(6)) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    B1 (IS PRODUCT PROBLEM), B2 (IS REQUIRED INTERVENTION), D3 (MANUFACTURER FAX) AND G1 (MANUFACTURER CONTACT FAX NUMBER) WERE ADDED AS THEY WERE NOT INCLUDED IN THE INITIAL REPORT. 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

    PATIENT PROFILE: 51-YEAR-OLD MALE WITH NO KNOWN PAST MEDICAL HISTORY WHO PRESENTED WITH SEVERE (10/10) CHEST PAIN, DIAPHORESIS, AND DYSPNEA FOR 6 HOURS. EVENT SUMMARY CHEST CT DEMONSTRATED A LARGE PERICARDIAL EFFUSION WITH LEFT VENTRICULAR FREE-WALL RUPTURE. EMERGENT TRANSFER TO THE CARDIAC CATHETERIZATION LABORATORY FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS UNDERTAKEN; HOWEVER, THE LEFT ANTERIOR DESCENDING ARTERY COULD NOT BE WIRED. AN IMPELLA CP WAS IMPLANTED FOR LEFT-SIDED MECHANICAL CIRCULATORY SUPPORT, AND CARDIAC SURGERY WAS CONSULTED. THE PATIENT UNDERWENT EMERGENT CORONARY ARTERY BYPASS GRAFTING CABG (SAPHENOUS VEIN GRAFT (SVG) TO THE LEFT ANTERIOR DESCENDING ARTERY (LAD)), LEFT VENTRICULAR FREE-WALL REPAIR, AND IMPELLA 5.5 IMPLANTATION FOR HIGHER-LEVEL LEFT VENTRICULAR SUPPORT WITH REMOVAL OF THE IMPELLA CP. THE PATIENT REQUIRED >20 UNITS OF BLOOD PRODUCTS DURING SURGERY. HE RETURNED TO THE OPERATING ROOM FOR RE-EXPLORATION DUE TO CONCERN FOR ONGOING BLEEDING; CLOT WAS EVACUATED, AND NO ACTIVE SOURCE IDENTIFIED, THOUGH ADDITIONAL BLOOD PRODUCTS WERE REQUIRED. DUE TO RIGHT VENTRICULAR FAILURE AFTER MASSIVE TRANSFUSION, THE SURGEON IMPLANTED AN IMPELLA RP FLEX VIA THE LEFT SUBCLAVIAN VEIN FOR RIGHT-SIDED MECHANICAL CIRCULATORY SUPPORT. CONTRARY TO THE DEVICE INSTRUCTIONS FOR USE (IFU), NO GUIDEWIRE WAS USED; THE SURGEON REPORTED MANUAL PALPATION OF THE CATHETER PASSING THE RIGHT ATRIUM (RA) RIGHT VENTRICLE (RV) PULMONARY ARTERY (PA)COURSE. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) COULD NOT VISUALIZE THE RP FLEX POSITION INTRA-PROCEDURE. THE PATIENT WAS TRANSPORTED TO THE ICU WITH AN OPEN CHEST, IMPELLA 5.5 AT P-4 (LV SUPPORT) AND IMPELLA RP FLEX AT P-9 (RV SUPPORT). CHEST X-RAY ON INTENSIVE CARE UNIT (ICU) ARRIVAL SHOWED THE RP FLEX MOTOR AND INLET IN THE INFERIOR VENA CAVA, WITH THE OUTLET DIRECTED TOWARD THE RIGHT ILIAC VEIN, CONSISTENT WITH MALPOSITION. THE RP FLEX SPEED WAS DECREASED TO P-2, AND A HEART TEAM DECISION WAS MADE TO REMOVE THE RP FLEX AT BEDSIDE AFTER 2.15 HOURS OF SUPPORT. HEMOSTASIS WAS ACHIEVED WITH A PURSE-STRING SUTURE AND PRESSURE DRESSING. POST-REMOVAL, THE PATIENT DEVELOPED DARK RED URINE FOLLOWING ADMINISTRATION OF CYANOKIT. HE REMAINED ON DOBUTAMINE, NOREPINEPHRINE, AND VASOPRESSIN WITH INCREASING VENTILATOR OXYGEN REQUIREMENTS. HE REMAINED IN CRITICAL CONDITION AND CONTINUED ON IMPELLA 5.5 SUPPORT FOR 6 DAYS, AFTER WHICH THE FAMILY ELECTED WITHDRAWAL OF CARE. THE PATIENT EXPIRED SHORTLY AFTER IMPELLA 5.5 REMOVAL. DETAILED EVENT CHRONOLOGY (RP FLEX¿SPECIFIC) INDEX SURGICAL COURSE. EMERGENT CABG (SVG LAD), LV FREE-WALL REPAIR, IMPELLA 5.5 PLACED; IMPELLA CP REMOVED. MASSIVE TRANSFUSION (>20 UNITS). RETURN TO OR FOR RE-EXPLORATION: CLOT EVACUATED; NO ACTIVE BLEEDING SOURCE FOUND. DECISION FOR RIGHT-SIDED SUPPORT. RIGHT VENTRICULAR FAILURE FOLLOWING MASSIVE TRANSFUSION DECISION TO IMPLANT IMPELLA RP FLEX. RP FLEX IMPLANTATION. ACCESS: LEFT SUBCLAVIAN VEIN. TECHNIQUE DEVIATION: GUIDEWIRE NOT USED; OPERATOR ADVANCED CATHETER BY MANUAL PALPATION (NON-IFU TECHNIQUE). TEE: UNABLE TO VISUALIZE DEVICE DURING PLACEMENT. PATIENT TRANSPORTED TO ICU OPEN CHEST WITH IMPELLA 5.5 (P-4) AND IMPELLA RP FLEX (P-9). ICU ARRIVAL ¿ MALPOSITION IDENTIFIED CXR: RP FLEX MOTOR & INLET IN THE IVC; OUTLET ORIENTED TOWARD RIGHT ILIAC VEIN MALPOSITION. MANAGEMENT: RP FLEX DECREASED TO P-2; PLAN FOR REMOVAL. RP FLEX REMOVAL BEDSIDE EXPLANT AT 2.15 HOURS OF SUPPORT. POST-REMOVAL COURSE DARK RED URINE NOTED FOLLOWING ADMINISTRATION OF CYANOKIT (A KNOWN SIDE EFFECT); ESCALATING VASOPRESSORS AND OXYGEN NEEDS. ONGOING IMPELLA 5.5 LV SUPPORT FOR 6 DAYS. FAMILY ELECTED WITHDRAWAL OF CARE PATIENT EXPIRED SHORTLY AFTER 5.5 REMOVAL. OUTCOME IMPELLA RP FLEX REMOVED AFTER 2.15 HOURS DUE TO MALPOSITION IDENTIFIED ON CHEST X-RAY (DEVICE COMPONENTS IN IVC WITH OUTLET AIMED CAUDALLY). PATIENT LATER EXPIRED AFTER 6 DAYS ON IMPELLA 5.5, FOLLOWING FAMILY-INITIATED WITHDRAWAL OF CARE. THE IMPELLA RP FLEX WILL BE CODED FOR MALPOSITION AND CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEVICE IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE UNDERLYING CRITICAL CLINICAL CONDITION. NOTE BODY (LOCAL LANGUAGE). AEI RECEIVED DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471387 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2025540970 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Death| R