BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP FLEX

    MDR report key: 21729736 · Received March 31, 2025

    Report

    Report Number
    1220648-2025-27081
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    February 13, 2025
    Report Date
    March 31, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED VIA LONG-TERM OUTCOME AND QUALITY INDICATOR (LOQI) IMPELLA REGISTRY DATABASE REPORTING TWO ADVERSE EVENTS. "FIRST ISCHEMIC STROKE MIDDLE CEREBRAL ARTERY AND SECOND MEDIASTINAL BLEEDING. CEREBRAL BLEED OF UNKNOWN RELATEDNESS AND BLEEDING OF POSSIBLE RELATIONSHIP. THE LOQ STATES THE FOLLOWING: AFTER THE PATIENT WAS EXTUBATED, HE DEVELOPED RIGHT-SIDED WEAKNESS, EXPRESSIVE AND RECEPTIVE APHASIA. INITIAL NIHSS WAS 23 POINTS FOR RIGHT FACIAL DROOP, APHASIA, RIGHT-SIDED WEAKNESS. NIHSS STABILIZED AT 8 POINTS ON (B)(6) 2025 AT 0730. CTA WAS NEGATIVE FOR LARGE VESSEL OCCLUSION, AND HE IS NOT A CANDIDATE FOR MRI DUE TO DURABLE LVAD. THE PATIENT HAD THREE CHEST TUBES PLACED ON (B)(6) 2025 DURING PROCEDURES (AORTIC VALVE REPLACEMENT, REDO STERNOTOMY, TAVR EXPLANT; IMPELLA RP FLEX IMPLANT). CHEST TUBE OUTPUT BETWEEN (B)(6) EQUATED TO GREATER THAN 2L IN A 24 HOUR PERIOD. THE SITE WAS ALSO NOTED TO BE "OOZY". BLOOD LOSS ALSO ATTRIBUTABLE TO REPEATED WIRING CATHETERS. ADMISSION (BASELINE) HEMOGLOBIN 13.7 G/DL, NADIR HEMOGLOBIN 6.6 G/DL (B)(6) 2025."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933078 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2024425653 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other