BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.0

    MDR report key: 19458181 · Received June 4, 2024

    Report

    Report Number
    1220648-2024-11956
    Event Type
    Injury
    Date Received
    June 4, 2024
    Date of Event
    July 25, 2021
    Report Date
    July 9, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE ACCESS SITE BLEEDING ¿ MAJOR ISSUE BEEN COMPLETED. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE ROOT CAUSE OF THE ACCESS SITE BLEEDING ISSUE WAS NOT DETERMINED SINCE THE PRODUCT WAS NOT RETURNED AND SUFFICIENT INFORMATION WAS NOT PROVIDED IN THE CLINICAL DESCRIPTION. B.7 REVISED AS THIS INFORMATION WAS ENTERED INCORRECTLY ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-11956. D.1 DEVICE NAME AND D.2 COMMON DEVICE NAME WERE REVISED AS THIS INFORMATION WAS PREVIOUSLY ENTERED INCORRECTLY ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-11956. D.4 MODEL NUMBER WAS REVISED AS THIS INFORMATION WAS PREVIOUSLY ENTERED INCORRECTLY ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-11956. E.1 FIRST NAME, LAST NAME AND FACILITY NAME WERE REVISED AS PREVIOUSLY ENTERED INCORRECTLY ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-11956. F.6 AND F.8 DATES WERE REPORTED ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-11956 AND SHOULD NOT HAVE BEEN. G.1 REVISED REPORTING CONTACT FAX NUMBER FROM MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-11956 IN ACCORDANCE WITH UPDATED PROCEDURES. G.3 DATE WAS ENTERED INCORRECTLY ON THE MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-11956. THE DATE SHOULD OF BEEN 02-MAY-2024. H.6 CODE 4114 WAS REPORTED INCORRECTLY ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-11956. A NEW CODE HAS BEEN ADDED TO TYPE OF INVESTIGATION CODES H.10 ADDITIONAL MANUFACTURER NARRATIVE INSTRUCTIONS FOR USE (IFUS) WERE REPORTED ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-11956 INCORRECTLY. NO IFUS ARE NEEDED TO BE REPORTED IN ACCORDANCE WITH UPDATED PROCEDURES.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. ¿ASSESS ACCESS SITE FOR BLEEDING AND HEMATOMA. ¿REMOVE THE PEEL-AWAY INTRODUCER COMPLETELY FROM THE ARTERY OVER THE CATHETER SHAFT TO PREVENT TRAUMA AND SIGNIFICANT BLEEDING AND APPLY MANUAL PRESSURE ABOVE THE PUNCTURE SITE.¿ ¿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.¿ OEZKUR, M., REDA, S., RÜHL, H., THEUERKAUF, N., KREYER, S., DUERR, G. D., CHARITOS, E., SILASCHI, M., MEDINA, M., ZIMMER, S., PUTENSEN, C., & TREEDE, H. (2021). ROLE OF ACQUIRED VON WILLEBRAND SYNDROME IN THE DEVELOPMENT OF BLEEDING COMPLICATIONS IN PATIENTS TREATED WITH IMPELLA RP DEVICES. SCIENTIFIC REPORTS, 11(1). HTTPS://DOI.ORG/10.1038/S41598-021-02833-8.

    Description of Event or Problem · 0

    ON 2024-05-02 COMPLAINTS TEAM FORWARDED PUBLICATION OUT OF BONN REGARDING 60 IMPELLA PATIENTS, 40 OF WHICH WERE IMPELLA 5.0. THE ENTITLED: "ROLE OF ACQUIRED VON WILLEBRAND SYNDROME IN THE DEVELOPMENT OF BLEEDING COMPLICATIONS IN PATIENTS TREATED WITH IMPELLA RP DEVICES" DETAILED COMPLICATIONS AS 9 MAJOR BLEED, 5 ECMO PLACEMENTS, 0 ACCESS SITE BLEED, AND 10 VW SYNDROME. PATIENTS WERE THOSE IMPLANTED FROM (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659739 IMPELLA 5.0 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.0 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Required Intervention