BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 19427746 · Received May 30, 2024

    Report

    Report Number
    1220648-2024-11819
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    December 15, 2023
    Report Date
    July 9, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    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 INTO THE ACCESS SITE BLEEDING ¿ MAJOR ISSUE BEEN COMPLETED. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. 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.7 REVISED AS THIS INFORMATION WAS INADVERTENTLY OMITTED FROM MANUFACTURER REPORT NUMBER 1220648-2024-11819. H.4 REVISED AS PREVIOUSLY ENTERED INCORRECTLY ON MANUFACTURER REPORT NUMBER 1220648-2024-11819. H.6 CODE 1888 WAS REPORTED INCORRECTLY ON MANUFACTURER REPORT NUMBER 1220648-2024-11819. A NEW CODE HAS BEEN ADDED TO HEALTH EFFECT - CLINICAL CODES. H.6 CODE 4114 WAS REPORTED INCORRECTLY ON MANUFACTURER REPORT NUMBER 1220648-2024-11819. A NEW CODE HAS BEEN ADDED TO TYPE OF INVESTIGATION CODES. H.10 ADDITIONAL MANUFACTURER NARRATIVE INSTRUCTIONS FOR USE WERE REVISED FROM MANUFACTURER REPORT NUMBER 1220648-2024-11819 IN ACCORDANCE WITH UPDATED PROCEDURES. ADDITIONAL MANUFACTURER NARRATIVE ON MANUFACTURER REPORT NUMBER 1220648-2024-11819 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: 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

    WE RECEIVED A NOTIFICATION VIA ABIOMED¿S LONG-TERM OUTCOME AND QUALITY INDICATOR IMPELLA REGISTRY REGARDING A PATIENT THAT ENDURED LARGE RIGHT GROIN HEMATOMA FORMATION WITH A "PROBABLE" RELATIONSHIP TO THE IMPELLA DEVICE USED: ¿ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION), CANNULATION WAS COMPLICATED BY LARGE RIGHT GROIN HEMATOMA FORMATION. " "(B)(6) 2023: HEMATOMA: PATIENT WITH BILATERAL GROIN HEMATOMA, WITH R>L POST ECMO BOTH ARE CURRENTLY SOFT AND COMPRESSIBLE. PLAN: -REGULAR ASSESSMENTS WITH COMPLETE BLOOD COUNT TWICE PER DAY" "RIGHT EXTERNAL ILIAC/SFA REPAIR WAS PERFORMED ON (B)(6) 2023: OVERNIGHT: HEMOGLOBIN WAS 6.4, RECEIVED 1 UNIT OF BLOOD WITH IMPROVEMENT TO 7.4" BASELINE HB PRIOR TO IMPLANTATION WAS 9.9 PT RECEIVED A TOTAL OF 4 UNITS OF RBCS 1 ON EACH OF (B)(6)." THE PATIENT RECOVERED WITH NO SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225019 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2024412246

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention