BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 19539381 · Received June 14, 2024

    Report

    Report Number
    1220648-2024-12439
    Event Type
    Injury
    Date Received
    June 14, 2024
    Date of Event
    June 2, 2024
    Report Date
    September 25, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR ACCESS SITE BLEEDING AND LIMB ISCHEMIA HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE ACCESS SITE BLEEDING WAS NOT DETERMINED AS INSUFFICIENT CLINICAL DATA WAS PROVIDED AND THE PRODUCT WAS NOT RETURNED. AS ALL THE NECESSARY INFORMATION WAS NOT PROVIDED, THE ROOT CAUSE OF THE LIMB ISCHEMIA WAS NOT DETERMINED. 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 INFORMATION WAS ADDED AS IT WAS INADVERTENTLY OMITTED FROM THE PREVIOUSLY SUBMITTED MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12439. D.4 REVISED MODEL NUMBER FROM THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12439 IN ACCORDANCE WITH UPDATED PROCEDURES. D.6B REVISED AS PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12439. F.6 AND F.8 DATES WERE REPORTED ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12439 AND SHOULD NOT HAVE BEEN. G.1 REVISED REPORTING CONTACT FAX NUMBER IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-12439 WAS SUBMITTED. H.6 CODES 3038 AND 925 WERE ADDED IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12439 WAS SUBMITTED. H.10 ADDITIONAL MANUFACTURER NARRATIVE INSTRUCTIONS FOR USE WERE REVISED FROM THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12439 IN ACCORDANCE WITH UPDATED PROCEDURES.

    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).¿

    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. PLACEMENT MONITORING WAS DISABLED ON THE FIRST OR SECOND DAY OF SUPPORT DUE TO ALARMS ABOUT PLACEMENT IN AORTA THAT WERE INCORRECT ACCORDING TO POSITION VERIFICATION BY ECHOCARDIOGRAPHY. AN OPTICAL SIGNAL ISSUE WAS SUSPECTED, BUT THE ROOT CAUSE WAS NOT DETERMINED SINCE THE PRODUCT WAS NOT RETURNED AND DATA LOGS WERE NOT PROVIDED. 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. G1 REPORTING CONTACT EMAIL UPDATED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 48-YEAR-OLD FEMALE UNDERGOING CARDIAC SURGERY WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. US COMPLAINANT REPORTED THE PATIENT WAS ON IMPELLA CP SUPPORT AND THEY DID NOT PULSES ON THEIR LEFT FOOT. VASCULAR SURGERY WAS CONSULTED, BUT THEY OPTED TO MONITOR. ADDITIONALLY, THE PLACEMENT SIGNAL MONITORING WAS DISABLED. STAFF CONFIRMED PLACEMENT. FURTHERMORE, THE PATIENT HAD OOZING AT THE ACCESS SITE. THE SITE WAS RE-SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390031 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025488269 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention