BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA RP FLEX

    MDR report key: 20981848 · Received December 19, 2024

    Report

    Report Number
    1220648-2024-24997
    Event Type
    Death
    Date Received
    December 19, 2024
    Date of Event
    December 8, 2024
    Report Date
    September 27, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    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

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE HAS NOT BEEN POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE STATE THE FOLLOWING: IMPELLA RP FLEX WITH SMARTASSIST INSTRUCTIONS FOR USE & CLINICAL REFERENCE MANUAL SECTION: USING THE AUTOMATED IMPELLA CONTROLLER WITH THE IMPELLA RP FLEX SMARTASSIST SYSTEM CATHETER USE OF THE REPOSITIONING SHEATH AND THE 23 FR PEEL-AWAY INTRODUCER ¿MAKE SURE THERE IS NO BLEEDING AT THE TRANSITION FROM THE REPOSITIONING SHEATH TO THE INTERNAL JUGULAR VEIN. CLOSE AND DRESS THE WOUND.¿ IMPELLA RP SYSTEM WITH AUTOMATED IMPELLA CONTROLLER & IMPELLA RP FLEX WITH SMART ASSIST SYSTEM WITH AUTOMATED IMPELLA CONTROLLER INSTRUCTIONS FOR USE & CLINICAL REFERENCE MANUAL SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES) ¿ARRHYTHMIA, ATRIAL FIBRILLATION, BLEEDING, CARDIAC TAMPONADE, CARDIOGENIC SHOCK, DEATH, DEVICE MALFUNCTION, HEMOLYSIS, HEPATIC FAILURE, INSERTION SITE INFECTION, PERFORATION, PHLEGMASIA CERULEA DOLENS (A SEVERE FORM OF DEEP VENOUS THROMBOSIS), PULMONARY VALVE INSUFFICIENCY, RESPIRATORY DYSFUNCTION, SEPSIS, THROMBOCYTOPENIA, THROMBOTIC VASCULAR (NON-CENTRAL NERVOUS SYSTEM COMPLICATION, TRICUSPID VALVE INJURY, CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION), VENOUS THROMBOSIS, VENTRICULAR FIBRILLATION AND/OR TACHYCARDIA.¿

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF ACCESS SITE BLEEDING AND VF/VT/AF/AT HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE CLINICAL DETAILS PROVIDED, THE ROOT CAUSE OF THE ACCESS SITE BLEED WAS DETERMINED TO MOST LIKELY BE ANTICOAGULATION MANAGEMENT. AS THE NECESSARY INFORMATION WAS NOT PROVIDED, THE ROOT CAUSE OF THE VT/VF WAS NOT DETERMINED E4 SHOULD HAVE BEEN LEFT BLANK ON MANUFACTURER DEVICE REPORT 1220648-2024-24997.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF OPTICAL SIGNAL ISSUES, PER FDA RECOMMENDATION. THE INVESTIGATION HAS BEEN COMPLETED. DATA LOGS WERE REVIEWED AND THE PLACEMENT SIGNAL NOT RELIABLE (PSNR) ALARM WAS CONFIRMED. RETURNED PRODUCT WAS INVESTIGATED AND THE PUMP PASSED ELECTRICAL TESTING AND HAD NO OTHER VISUAL ABNORMALITIES. BASED ON RETURNED PRODUCT AND DATA LOG REVIEW, THE ROOT CAUSE OF THE PLACEMENT SIGNAL ISSUE WAS DETERMINED TO BE SENSOR DRIFT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUSPECT PRODUCT AND HISTORICAL COMPLAINT DATA WAS CONDUCTED. THIS REVIEW REVEALED THAT THE PRODUCT MET ALL MANUFACTURING RELEASE CRITERIA, AND NO PRODUCT DEFICIENCIES WERE IDENTIFIED AT THE TIME THE PRODUCT WAS MANUFACTURED AND RELEASED TO THE CUSTOMER. ALL PERTINENT INFORMATION AVAILABLE TO ABIOMED HAS BEEN SUBMITTED AT THIS TIME. B1 PRODUCT PROBLEM UPDATED. H6 UPDATED TO INCLUDE OPTICAL SIGNAL CODING. CORRECTIONS THAT WERE MADE FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24997. D8/D9 DEVICE RETURNED TO MANUFACTURER UPDATED. D10 CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES UPDATED.

    Description of Event or Problem · 0

    US COMPLAINANT REPORTED THE PATIENT WAS ON IMPELLA RP FLEX SUPPORT AND DURING SUPPORT, THERE WERE PLACEMENT SIGNAL NOT RELIABLE ALARMS. POSITION WAS CONFIRMED AND SUPPORT CONTINUED. ADDITIONALLY, THE PATIENT HAD ACCESS SITE BLEEDING. TWO UNITS OF PACKED RED BLOOD CELLS WERE GIVEN TO THE PATIENT, AND HEPARIN WAS WITHHELD. FURTHERMORE, THE PATIENT HAD VENTRICULAR FIBRILLATION (VF) WHILE ON SUPPORT. THE PATIENT WAS DEFIBRILLATED, AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED. THE PATIENT EXPIRED AFTER 11.07 HOURS OF IMPELLA SUPPORT AFTER THE FAMILY DECIDED TO WITHDRAW CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280435 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2025551163

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Death AUTOMATED IMPELLA CONTROLLER