BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24844956 · Received April 10, 2026

    Report

    Report Number
    1220648-2026-06645
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    April 3, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED D3 MANUFACTURER FAX WAS OMITTED DURING INITIAL REPORT. CORRECTED D4 SERIAL NUMBER. UPDATED D4 PRIMARY UDI NUMBER. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS USE RELATED AS THE CP ACCESS SITE WAS CLOSED BY A MANTA DEVICE THAT FAILED AND ALLOWED FOR THE PATIENT TO DEVELOP A HEMATOMA AT THE ACCESS.

    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: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 69 YEAR OLD MALE PATIENT ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE AND A PLAN FOR PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PATIENT WAS SUPPORTED BY AN INTRA-AORTIC BALLOON PUMP PRIOR TO THE CP PUMP AND WAS KNOWN TO BE IN SCAI STAGE C SHOCK. THE OTHER UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE CP ALLOWED FOR THE PCI AND WAS THEN EXPLANTED AS HEMODYNAMIC SUPPORT NO LONGER NECESSARY. THE CP ACCESS SITE WAS CLOSED BY A MANTA DEVICE THAT FAILED AND ALLOWED FOR THE PATIENT TO DEVELOP A HEMATOMA AT THE ACCESS. MANUAL PRESSURE WAS APPLIED AND THE PATIENT SURVIVED THE INJURY. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906620 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027855346 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other