BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 19034135 · Received April 3, 2024

    Report

    Report Number
    1220648-2024-09340
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    November 14, 2023
    Report Date
    September 24, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: ¿POTENTIAL ADVERSE EVENTS (UNITED STATES) ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND VASCULAR INJURY¿.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE ACCESS SITE BLEED HAS BEEN COMPLETED. PUMP WAS NOT RETURNED FOR INVESTIGATION. INFORMATION RELATED TO HEMATOMA AT ACCESS SITE IS NOT PROVIDED IN THE CLINICAL DETAILS. THEREFORE, THE ROOT CAUSE OF THE ACCESS SITE BLEEDING ISSUE WAS NOT DETERMINED SINCE PRODUCT WAS NOT RETURNED AND INSUFFICIENT CLINICAL INFORMATION PROVIDED. THE INSTRUCTIONS FOR USE FOR THE IMPELLA 5.5 WITH SMART ASSIST FOR USE DURING CARDIOGENIC SHOCK SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES): ¿ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION)¿ CORRECTIONS TO THE INITIAL MFR REPORT: G1 MDR REPORTING CONTACT EMAIL. H6 COMPONENT CODE 925.

    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. PUMP WAS NOT RETURNED FOR INVESTIGATION. DATA LOGS WERE INVESTIGATED, AND A PLACEMENT SIGNAL NOT RELIABLE (PSNR) ALARM WAS OBSERVED. THE PLACEMENT SIGNAL (PS) GOES TO 3000 AND NEVER RECOVERS, SIGNAL-TO-NOISE RATIO (SNR) DROPS TO 0, LAMP GOES TO 100, CONTRAST IS A SPREAD, GAIN INCREASES AND LIGHT DECREASES. THESE SYMPTOMS ARE SIMILAR TO THAT OF A FIBER BREAK SINCE THE PS DOESN'T RECOVER. THEREFORE, THE ROOT CAUSE OF THE OPTICAL SIGNAL ISSUE WAS MOST LIKELY A DAMAGED OPTICAL FIBER LINE DUE TO EXCESSIVE FORCE. 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 . D10 CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES UPDATED. G1 REPORTING CONTACT FAX NUMBER UPDATED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 43-YEAR-OLD MALE IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT DEVELOPED A HEMATOMA AT THE IMPELLA SITE. THE PLAN WAS TO EVACUATE. THE PATIENT RECEIVED PACKED RED BLOOD CELLS. PATIENT IS STABLE POST ISSUE.

    Description of Event or Problem · 0

    THE COMPLAINANT ALSO REPORTED THAT THE OPTICAL SIGNAL WAS LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757768 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2024405063 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Required Intervention AUTOMATED IMPELLA CONTROLLER