BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_INTRODUCER

    MDR report key: 24620010 · Received March 17, 2026

    Report

    Report Number
    1220648-2026-05458
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    February 21, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D PRODUCT INFORMATION IS NOT KNOWN. 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

    E4 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    Description of Event or Problem · 0

    CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS PLACED VIA THE RIGHT FEMORAL ARTERY TO SUPPORT A 52 YEAR OLD MALE PATIENT ADMITTED FOR ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, IN SCAI STAGE E SHOCK. THERE WAS NO OTHER MEDICAL HISTORY SHARED. DURING IMPLANT, WHEN ATTEMPTING TO PASS THE COMPANION SHEATH THROUGH THE PEEL-AWAY SHEATH, EXCESS BLEEDING OCCURRED AND COULD NOT FULLY PASS THROUGH THE HEMOSTATIC VALVE. A NEW COMPANION SHEATH WAS SUCCESSFULLY USED. THE PATIENT RECEIVED SUPPORT WITH THE CP FOR THE PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. BLEEDING IS A KNOWN RISK ASSOCIATED WITH IMPELLA CP AS DESCRIBED IN THE INSTRUCTIONS FOR USE. THE FAILURE TO ADVANCE WILL BE CONSERVATIVELY REPORTED FOR HEMODYNAMIC INSTABILITY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE, HOWEVER THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT AND SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433503 UNK_INTRODUCER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1