BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25122172 · Received May 8, 2026

    Report

    Report Number
    1220648-2026-07657
    Event Type
    Death
    Date Received
    May 8, 2026
    Date of Event
    April 27, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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: A 78-YEAR-OLD MALE UNDERWENT A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) ON (B)(6) 2026 WITH IMPELLA CP SUPPORT (S/N (B)(6)) VIA RIGHT FEMORAL PERCUTANEOUS ARTERIAL ACCESS. THE PATIENT¿S PRE-SUPPORT CLINICAL STATE WAS CONSISTENT WITH SCAI SHOCK STAGE A. THE IMPELLA CP WAS IMPLANTED AT 4:04 PM AND EXPLANTED AT 5:11 PM IN THE PROCEDURAL AREA. THE HRPCI WAS REPORTED AS SUCCESSFUL; HOWEVER, HEMOSTASIS AT THE ACCESS SITE WAS DIFFICULT TO ACHIEVE FOLLOWING DEVICE REMOVAL, REQUIRING THREE PERCLOSE ATTEMPTS FOLLOWED BY BALLOON TAMPONADE AND MANUAL PRESSURE. BLEEDING WAS CONTROLLED, AND THE PATIENT WAS TRANSFERRED TO THE POST-PROCEDURAL AREA. THE PATIENT WAS SUBSEQUENTLY RETURNED TO THE CARDIAC CATHETERIZATION LABORATORY FOR RIGHT HEART CATHETERIZATION, WITH VALUES REPORTED AS NORMAL, AND WAS THEN TRANSFERRED TO THE UNIT. OVERNIGHT, THE PATIENT DEVELOPED COMPLICATIONS RELATED TO ACCESS SITE BLEEDING AT THE ARTERIOTOMY AND VESSEL, ASSOCIATED WITH REMOVAL OF THE IMPELLA SHEATH. A VESSEL PERFORATION OR DISSECTION WAS REPORTED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR VASCULAR INTERVENTION. DESPITE MANAGEMENT, THE PATIENT EXPIRED ON (B)(6) 2026. BASED ON AVAILABLE INFORMATION, THE EVENT INVOLVED ACCESS SITE BLEEDING FOLLOWING IMPELLA CP SUPPORT DURING AN HRPCI, WITH SUBSEQUENT VASCULAR COMPLICATIONS AND PATIENT DEATH THE FOLLOWING DAY. BASED ON THE AVAILABLE INFORMATION, THERE WAS NO CONFIRMED DEVICE MALFUNCTION, AND DEVICE OUTCOME INVOLVEMENT REMAINS UNKNOWN. THE PATIENT DEATH OCCURRED AFTER DEVICE EXPLANT AND WAS TEMPORALLY ASSOCIATED WITH ACCESS-RELATED VASCULAR COMPLICATIONS; ATTRIBUTION TO THE IMPELLA DEVICE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. BLEEDING IS CONSISTENT WITH ACCESS SITE COMPLICATIONS AS A RESULT OF LARGE BORE FEMORAL PROCEDURES AND THE ANTICOAGULATION AND PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT. IT IS UNKNOWN WHETHER RECOMMENDED BEST PRACTICES FOR ACCESS MANAGEMENT WERE FOLLOWED TO MITIGATE THE RISK OF BLEEDING. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA CP BUT IS UNLIKELY RELATED AND IS MOST LIKELY ATTRIBUTED TO PATIENTS UNDERLYING CRITICAL CONDITION AS THEY PRESENTED IN SCAI STAGE A SHOCK ON MULTIPLE INOTROPES AND PRESSORS AND WAS VENTILATED FOR RESPIRATORY SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392652 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027840998 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Death| R