BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25187005 · Received May 15, 2026

    Report

    Report Number
    1220648-2026-07916
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    May 9, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN H3 (DEVICE EVALUATED BY MANUFACTURER?), H5 (LABELED FOR SINGLE USE?). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY SUBMITTED IN ERROR IN THE INITIAL REPORT. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 60-YEAR-OLD MALE FOR ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK (AMI/CGS), PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) SHOCK STAGE E. DURING SUPPORT, A PROACTIVE COMMUNICATION FROM THE CLINICAL TEAM INDICATED THAT THE PATIENT DEVELOPED HEMATURIA. AT THE TIME OF THE EVENT, THE PATIENT WAS RECEIVING VASOPRESSOR SUPPORT WITH LEVOPHED AND VASOPRESSIN. THE IMPELLA CP DEVICE WAS OPERATING AT PERFORMANCE LEVEL 9 WITH A REPORTED MEAN ARTERIAL PRESSURE (MAP) ABOVE 100 MMHG. TROUBLESHOOTING USING ECHOCARDIOGRAPHY, WHICH WAS IN PROGRESS AT THE TIME OF REPORTING. RECOMMENDATIONS WERE MADE TO THE CARE TEAM TO CONSIDER GRADUAL WEANING OF VASOPRESSOR SUPPORT AND ADJUSTMENT OF IMPELLA SUPPORT LEVELS IN ALIGNMENT WITH ABIOMED HEMODYNAMIC MANAGEMENT GUIDELINES, PARTICULARLY TARGETING APPROPRIATE MAP RANGES TO REDUCE RISK OF HEMOLYSIS. THE REPORTING CLINICIAN NOTED INTENT TO DISCUSS THESE RECOMMENDATIONS WITH THE TREATING TEAM. BASED ON THE AVAILABLE INFORMATION, THE REPORTED HEMATURIA IS CONSISTENT WITH POTENTIAL HEMOLYSIS IN THE SETTING OF ELEVATED PUMP SUPPORT AND INCREASED MAP. THE PATIENT REMAINS ON IMPELLA SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403541 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027863678 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1