BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 19459573 · Received June 4, 2024

    Report

    Report Number
    1220648-2024-11995
    Event Type
    Injury
    Date Received
    June 4, 2024
    Date of Event
    May 29, 2024
    Report Date
    July 23, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED LIMB ISCHEMIA HAS BEEN COMPLETED. THE DEVICE NOR SUFFICIENT CLINICAL INFORMATION WAS RETURNED FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE LIMB ISCHEMIA COULD NOT BE DETERMINED. A.5 ETHNICITY WAS SELECTED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-11995. ETHNICITY IS UNKNOWN. B.5 THE DEVICE WAS EXPLANTED AT THE TIME OF THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-11995 AND WAS REPORTED INCORRECTLY ON THAT REPORT. B.7 ADDED INFORMATION AS IT WAS INADVERTENTLY OMITTED FROM INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-11995. D.6B REVISED FROM THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT 1220648-2024-11995 IN ACCORDANCE WITH UPDATED PROCEDURES. F.6 AND F.8 DATES WERE REPORTED ON MANUFACTURER DEVICE REPORT 1220648-2024-11995 AND SHOULD NOT HAVE BEEN. G.1 REVISED REPORTING CONTACT FAX NUMBER IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-11995 WAS SUBMITTED. H.6 ADDED CODE 3038 SINCE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT 1220648-2024-11995 IN ACCORDANCE WITH UPDATED PROCEDURES. H.6 CODES 4114 AND 4624 WERE REPORTED INCORRECTLY ON THE PREVIOUSLY SUBMITTED MANUFACTURER DEVICE REPORT 1220648-2024-11995. NEW CODES HAS BEEN ADDED TO TYPE OF INVESTIGATION CODES AND HEALTH EFFECT - IMPACT CODES. H.10 ADDITIONAL MANUFACTURER NARRATIVE ON THE PREVIOUSLY SUBMITTED MANUFACTURER DEVICE REPORT 1220648-2024-11995 STATED THAT THE DEVICE WAS NOT RETURNED BUT THE DEVICE WAS DISCARDED. TYPE OF INVESTIGATION CODES HAS BEEN UPDATED TO REFLECT DISCARDED.

    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: IMPELLA CP WITH SMART ASSIST SYSTEM. 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.)¿

    Description of Event or Problem · 0

    THE IMPELLA DEVICE WAS EXPLANTED THREE DAYS AFTER THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT DURING CARDIAC SURGERY. WHILE ON SUPPORT, A FEM-FEM EXTERNAL BYPASS NEEDED TO SUPPLY BLOOD FLOW TO DISTAL LIMB. THE PEEL AWAY SHEATH WAS REMOVED AT TIME OF INSERTION. THE PATIENT IS STABLE. THE PATIENT REMAINS ON IMPELLA CP SUPPORT ON THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150088 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025480400 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention