BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23485898 · Received November 6, 2025

    Report

    Report Number
    1220648-2025-48140
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 6, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT INVESTIGATION CLOSURE. INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED FOR INVESTIGATION. MAJOR BLEED: OOZING FROM MULTIPLE SITE SINCE SHE RECEIVED THROMBOLYTIC IN ER. FEMSTOP APPLIED AT IMPELLA SITE. THE ROOT CAUSE OF THE BLEEDING IS DETERMINED TO BE PATIENT CONDITION BECAUSE OF THE BLEEDING FROM MULTIPLE SITES. HEMATOMA: HEMATOMA OF THE RIGHT GROIN RESOLVED. THE CAUSE OF THE HEMATOMA WAS UNABLE TO BE DETERMINED AS INSUFFICIENT CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR ANALYSIS. DEVICE HISTORY LOT: DEVICE LOT: 1992905. DEVICE HISTORY REVIEW: DEVICE WITH SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN B5 (EVENT DESCRIPTION). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED: THE PATIENT RECEIVED TISSUE PLASMINOGEN ACTIVATOR (TPA) BEFORE IMPELLA USE. ACCORDING TO THE SALES DOCUMENTATION, THE EVENT WAS DETERMINED NOT TO BE RELATED TO THE IMPELLA DEVICE. THE ISSUE RESOLVED ONCE THE HALF-LIFE OF TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS REACHED. THE PATIENT RECOVERED AND WAS DISCHARGED HOME.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF CHEST PAIN AND AN ELECTROCARDIOGRAM REVEALED THE PATIENT WAS IN ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT RECEIVED TENECTEPLASE AND THEN EXPERIENCED CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION WAS PERFORMED AND RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED. THE PATIENT WAS BROUGHT TO THE CARDIAC CATHETERIZATION LABORATORY FOR LEFT HEART CATHETERIZATION (LHC) AND PERCUTANEOUS CORONARY INTERVENTION (PCI). LHC REVEALED A BLOCKAGE OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY AND A STENT WAS PLACED SUCCESSFULLY. THE PATIENT¿S LACTIC ACID RESULTS WERE 10 MMOL/L AND THE MEDICAL TEAM DECIDED TO IMPLANT THE IMPELLA CP. ON DAY 1 OF SUPPORT, THE PATIENT EXPERIENCED OOZING FROM MULTIPLE SITES, WHICH THE MEDICAL TEAM ATTRIBUTED TO THE PATIENT RECEIVING TENECTEPLASE IN THE EMERGENCY DEPARTMENT. A FEMSTOP WAS APPLIED TO THE IMPELLA SITE TO RESOLVE THE BLEEDING. THE FOLLOWING DAY, IT WAS NOTED THAT A HEMATOMA AT THE RIGHT GROIN OF THE IMPELLA ACCESS SITE HAD RESOLVED. THE PATIENT HAD RECEIVED ALBUMIN OVERNIGHT TO MANAGE FLUID BALANCE FOLLOWING DIURESIS AND BLEEDING. OF NOTE, THERE WERE NO IMPELLA RELATED ISSUES REPORTED. ON DAY 5 OF SUPPORT, IT WAS NOTED THAT THE PATIENT WAS TRANSFUSED WITH ONE UNIT OF PACKED RED BLOOD CELLS. THE DEVICE WAS EXPLANTED SUCCESSFULLY AFTER WEANING. THE EXPLANT WAS NOT CONSIDERED PREMATURE AND WAS UNRELATED TO THE REPORTED COMPLICATION. THE PATIENT'S OUTCOME AT THE TIME OF EXPLANT WAS SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2637711 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026762919 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention