BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24649142 · Received March 20, 2026

    Report

    Report Number
    1220648-2026-05714
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    March 16, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED. 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

    PPAE (INFECTION) : THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. CORRECTION HAS BEEN UPDATED IN D1 (BRAND NAME). ADDITIONAL INFORMATION HAS BEEN PROVIDED IN H6 (COMPONENT CODE, INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, AND INVESTIGATION CONCLUSIONS).

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 75-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF A CORONARY ARTERY BYPASS GRAFT (CABG), PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN AN OUT-OF-HOSPITAL CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR), IN SCAI STAGE E SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA 5.5 WAS INSERTED AS AN ESCALATION OF THERAPY FROM AN IMPELLA CP. TEN DAYS AFTER IMPELLA INSERTION, THE DEVICE WAS SUCCESSFULLY WEANED. DURING EXPLANT, AN INFECTION WAS NOTED IN THE POCKET BY THE PHYSICIAN. THE POCKET WAS WASHED OUT. WHITE BLOOD CELLS (WBC) WERE ELEVATED. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AT P-4 AT 2.1L/MIN AS INTENDED. RISK OF INFECTION OFTEN CORRELATES WITH THE PATIENT'S UNDERLYING CRITICAL CLINICAL CONDITION, DURATION OF MECHANICAL SUPPORT, OTHER POTENTIAL SOURCES INCLUDING PERIPHERALLY INSERTED CATHETER LINES, MULTIPLE CANNULATION SITES, OR THE DEVICE ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713896 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027818937 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention