BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 21067493 · Received January 3, 2025

    Report

    Report Number
    1220648-2025-25299
    Event Type
    Injury
    Date Received
    January 3, 2025
    Date of Event
    December 14, 2024
    Report Date
    February 3, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI# FOR THE AIC IS UNKNOWN. DEVICE HAS BEEN RETURNED AS OF (B)(6) 2025, AND EVALUATION IS PENDING . ONCE COMPLETED A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED VENTRICULAR TACHYCARDIA (VT) HAS BEEN COMPLETED. THE DEVICE NOR SUFFICIENT CLINICAL INFORMATION WAS RETURNED FOR EVALUATION. AS THE NECESSARY INFORMATION WAS NOT PROVIDED, THE ROOT CAUSE OF THE VT WAS NOT DETERMINED. B.1 REVISED SELECTION TO ADVERSE EVENT AS IT WAS PREVIOUSLY ENTERED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25299. B.2 REVISED AS A REQUIRED INTERVENTION SHOULD OF BEEN SELECTED ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25299. B.5 REVISED DESCRIBE EVENT OR PROBLEM AS IT WAS PREVIOUSLY ENTERED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25299. MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25362 WAS SUBMITTED TO REPRESENT THE AUTOMATED IMPELLA CONTROLLER EVENT. D.1 REVISED BRAND NAME AS IT WAS PREVIOUSLY ENTERED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25299. D.4 REVISED SECTION AS IT WAS PREVIOUSLY ENTERED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25299. D.9 REVISED AS PREVIOUSLY ENTERED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25299. G.1 REVISED REPORTING CONTACT EMAIL SINCE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25299 WAS SUBMITTED IN ACCORDANCE WITH UPDATED PROCEDURES. H.1 REVISED SELECTION TO ADVERSE EVENT AS IT WAS PREVIOUSLY ENTERED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25299. H.3 REVISED SELECTIONS AS THEY WERE PREVIOUSLY ENTERED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25299. H.5 REVISED AS PREVIOUSLY ENTERED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25299. H.6 CODES WERE REVISED TO REFLECT THE CORRECT INFORMATION IN B.5 AS THEY WERE PREVIOUSLY ENTERED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25299. H.8 REVISED AS PREVIOUSLY ENTERED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25299. H.10. THE PUMP WAS NOT RETURNED. THEREFORE, THE ADDITIONAL MANUFACTURER NARRATIVE ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-25299 WAS INCORRECT TO SAY THAT THE DEVICE HAD BEEN RETURNED.

    Description of Event or Problem · 0

    US COMPLAINANT REPORTED THE PATIENT WAS ON IMPELLA SUPPORT AND DURING SUPPORT, THE AUTOMATIC IMPELLA CONTROLLER (AIC) HAD PERSISTENT "PURGE DISC NOT DETECTED" ALARMS. THE PURGE TUBING WAS REPLACED TO NO AVAIL. THE AIC WAS REPLACED AND SUPPORT CONTINUED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT HAD AN IMPELLA 5.5 IMPLANT AND DURING THE IMPLANT, THE PATIENT HAD VENTRICULAR TACHYCARDIA (VT). WHEN ADVANCING THE WIRE ACROSS THE VALVE AND INTO THE LV, THE PATIENT HAD SUSTAINED VT REQUIRING DEFIBRILLATION AT 200J ONCE. THE PATIENT WAS PRONE TO ARRYTHMIA. HOWEVER, IT IS UNKNOWN IF THE IMPELLA IMPLANT CONTRIBUTED TO THE VT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600121 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025574184 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention