BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP FLEX

    MDR report key: 20766971 · Received November 23, 2024

    Report

    Report Number
    1220648-2024-24091
    Event Type
    Injury
    Date Received
    November 23, 2024
    Date of Event
    November 11, 2024
    Report Date
    September 25, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. AS NOTED IN THE IMPELLA IFU: 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.¿.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF ACCESS SITE BLEEDING HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE ACCESS SITE BLEEDING - MAJOR WAS UNABLE TO BE DEFINITIVELY DETERMINED AS SEVERAL POSSIBLE CONTRIBUTING FACTORS WERE POTENTIAL CAUSES OF BLEEDING. H6 HEALTH EFFECT - IMPACT CODE 4643 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24091.

    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 CONFIRM PLACEMENT SIGNAL NOT RELIABLE (PSNR) ALARM. THERE WAS A MOTOR CURRENT SPIKE, SPEED DEVIATION, AND IMMEDIATE LOSS OF CENTRAL VENOUS PRESSURE. THE DP SENSOR REMAINED STABLE. THE ROOT CAUSE OF THE OPTICAL ISSUE WAS MOST LIKELY A DAMAGED SENSOR FACE. 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. B5 UPDATED TO INCLUDE OPTICAL SIGNAL ISSUE DESCRIPTION. H6 UPDATED TO INCLUDE OPTICAL SIGNAL CODING. CORRECTIONS THAT WERE MADE FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER. B7 OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS. D10 CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT HAD ACCESS SITE BLEEDING. THE PATIENT WAS HEMORRHAGING AT THE ACCESS SITE. THE PATIENT REQUIRED 4 UNITS OF PACKED RED BLOOD CELLS, 2 UNITS OF PLATELETS, AND AN INCREASE IN VASOPRESSORS IN ORDER TO MAINTAIN GOAL MEAN ARTERIAL BLOOD PRESSURES. A HEMOSTATIC SUTURE WAS APPLIED, AND HEPARIN WAS WITHHELD. THE STAFF STATED THAT THE BLEEDING WAS LIKELY DUE TO OVER-ANTICOAGULATION FROM SYSTEMIC HEPARIN. SUPPORT WAS CONTINUED, NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    THE COMPLAINANT ADDITIONALLY REPORTED THAT A PLACEMENT SIGNAL NOT RELIABLE ALARM APPEARED DURING SUPPORT TWO DAYS LATER. THERE WAS NO IMPACT ON SUPPORT, AND POSITIONING WAS VERIFIED TO BE ACCURATE. SUPPORT CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2594513 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2025502628 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention AUTOMATED IMPELLA CONTROLLER