BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25024114 · Received April 28, 2026

    Report

    Report Number
    1220648-2026-07187
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    April 21, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    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

    AN IMPELLA 5.5 WAS BEING INSERTED VIA THE LEFT AXILLARY ARTERY GRAFT SITE TO SUPPORT THE 77 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE AND A PLAN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PATIENT PRESENTED IN SCAI STAGE D SHOCK, AND PREVIOUSLY SUPPORTED BY INOTROPES, VASOPRESSORS, AND A VENT FOR RESPIRATORY NEEDS. THE PATIENT HAD KNOWN AV FISTULA IN THE RIGHT ARM FOR DIALYSIS AND PERIPHERAL ARTERIAL DISEASE WITH CALCIFICATION. THE TEAM REPEATEDLY ATTEMPTED TO PLACE THE 5.5 BUT, DESPITE EXCHANGES OF THE GUIDEWIRES AND DIAGNOSTIC CATHETERS, THE 5.5 FAILED TO DELIVER. RESISTANCE WAS MET AND THE PUMP COULD NOT ADVANCE BEYOND THE SUBCLAVIAN AORTIC ARCH TURN. THEY SWAPPED OUT WITH A CP PUMP, WHICH DID EVENTUALLY DELIVER TO THE LEFT VENTRICLE AND SUPPORT WAS INITIATED. THIS CP WAS ABLE TO BE DELIVERED BUT THE SITE OF ACCESS WAS OBSERVED TO BE SATURATED AND SO THEY CLOSED WITH NYLON STICHES, PLACED A JP DRAIN, AND GAVE 1 UNIT OF BLOOD. THEY ALSO GAVE PROTAMINE TO REVERSE THE HEPARIN AND APPLIED PRESSURE. ALL THESE MEASURES SLOWED THE BLOOD LOSS FROM THE ACCESS SITE OF THE CP. PATIENT REMAINED ON SUPPORT FOR 3 DAYS TIL WEANED AND EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085124 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. 2026776597 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention