BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 19691539 · Received July 8, 2024

    Report

    Report Number
    1220648-2024-12985
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    June 28, 2024
    Report Date
    September 11, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    04260113630280
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED ACCESS SITE BLEED HAS BEEN COMPLETED. THE DEVICE NOR SUFFICIENT CLINICAL INFORMATION WAS RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE ACCESS SITE BLEEDING COULD NOT BE DETERMINED SINCE THE PRODUCT WAS NOT RETURNED AND INSUFFICIENT CLINICAL DETAILS WERE PROVIDED. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA CP WITH SMART ASSIST SYSTEM SECTION: GENERAL PATIENT CARE CONSIDERATIONS ¿ASSESS ACCESS SITE FOR BLEEDING AND HEMATOMA.¿ SECTION: ENTERING CARDIAC OUTPUT USE OF THE REPOSITIONING SHEATH AND PEEL-AWAY INTRODUCER ¿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.¿ 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).¿ B.2 OTHER SERIOUS WAS SELECTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12985. D.4 UNIQUE IDENTIFIER (UDI) # WAS REVISED AS IT WAS ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12985. E.1 ADDRESS LINE 1 WAS REVISED AS IT WAS ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12985. G.1 MANUFACTURING SITE ADDRESS LINE 1 AND 2 WERE REVISED AS THEY WERE ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12985. G.2 REVISED AS INFORMATION WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12985. H.6 COMPONENT CODE SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12985 WAS ENTERED INCORRECTLY AND A NEW CODE HAS BEEN ADDED. H.10 ADDITIONAL MANUFACTURER NARRATIVE INSTRUCTIONS FOR USE WERE REVISED FROM THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12985 IN ACCORDANCE WITH UPDATED PROCEDURES.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE HAS NOT BEEN POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE STATE THE FOLLOWING: SECTION: GENERAL PATIENT CARE CONSIDERATIONS ¿ASSESS ACCESS SITE FOR BLEEDING AND HEMATOMA.¿ SECTION: ENTERING CARDIAC OUTPUT USE OF THE REPOSITIONING SHEATH AND PEEL-AWAY INTRODUCER ¿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.¿ 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 COMPLAINANT REPORTED A 80-YEAR-OLD FEMALE PATIENT WITH ACUTE MYOCARDIAL INFARCTION / CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. THE COMPLAINANT REPORTED THE PATIENT DEVELOPED SIGNIFICANT BLEEDING AT THE GROIN SITE. THE PHYSICIAN REPORTED THAT THE CAUSE OF THE BLEEDING COULD WELL BE AN ACCIDENTAL PUNCTURE. MEDICAL STAFF ADMINISTERED FOUR BAGS OF BLOOD AND A HEMOGLOBIN DRIP. VASCULAR SURGERY CLOSED THE DAMAGE. THE PATIENT SURVIVED THE EVENT AND WAS SUCCESSFULLY WEANED, WITH THE DEVICE EXPLANTED FOUR DAYS LATER WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170674 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2024415167 04260113630280

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention| O