BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24753281 · Received April 1, 2026

    Report

    Report Number
    1220648-2026-06234
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 6, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PPAE(MAJOR BLEED): THE ROOT CAUSE OF THE GI BLEED WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. ADDITIONAL INFORMATION (CODES) HAS BEEN PROVIDED IN H6 (COMPONENT CODE, INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, AND INVESTIGATION CONCLUSIONS).

    Additional Manufacturer Narrative · 0

    D6B UPDATED. CORRECTED DATA. D4 CATALOG NUMBER UPDATED/CORRECTED. THE INVESTIGATION IS STILL ONGOING.

    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 RP FLEX DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT INTERNAL JUGULAR VEIN IN A 76-YEAR-OLD FEMALE PATIENT PRESENTING IN RIGHT HEART FAILURE, IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI STAGE E SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT HAD AN ACTIVE GASTROINTESTINAL (GI) BLEED. THE HEPARIN DRIP WAS REDUCED. THE PATIENT WAS BROUGHT INTERVENTIONAL RADIOLOGY (IR) FOR AN EMBOLIZATION OF SOURCE OF BLEED. THE PATIENT RECEIVED 2 UNITS PACKED RED BLOOD CELLS (PRBCS). HEMODYNAMICS WERE STABLE. THE POST-PROCEDURE OUTCOME IS UNKNOWN. THE IMPELLA FUNCTIONED AT P-6 AT 3.3LMIN AS INTENDED. BLEEDING IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819203 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026794144 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention