BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23741121 · Received December 8, 2025

    Report

    Report Number
    1220648-2025-48809
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 8, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: ADDED CODE C13 TO THE INVESTIGATION FINDINGS. H11: ADDED THE RESULTS OF THE INVESTIGATION INVESTIGATION SUMMARY NO PRODUCT WAS RETURNED. ACCESS SITE ADVERSE EVENT: THE CAUSE OF THE BLEED WAS MOST LIKELY USE ISSUE RELATED SINCE HEMOSTASIS WAS ACHIEVED BY ADDING ADDITIONAL PURSE STITCH ALONG WITH ANGLE MATCHING. DEVICE HISTORY LOT DEVICE LOT: 1951051 DEVICE HISTORY REVIEW DEVICE SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. 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).¿

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, IT WAS REPORTED THAT THERE WAS SIGNIFICANT ACCESS SITE BLEED. A PURSE STITCH WAS APPLIED, FORWARD TENSION AT THE HUB, VERTICAL ANGLE MATCHING PERPENDICULAR TO SITE, AND GAUZE SURROUNDING THE REPOSITIONING SHEATH. 14 UNITS OF PACKED RED BLOOD CELLS WERE GIVEN. LATER, THE PUMP WAS EXPLANTED AND THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2454049 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026708299 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention