BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24764805 · Received April 2, 2026

    Report

    Report Number
    1220648-2026-06282
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 25, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FOR D6 EXPLANT.

    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.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4 (SERIAL NUMBER). UPON REVIEW, THE SECTION D SERIAL NUMBER HAS NOW BEEN UPDATED. CORRECTED INFORMATION WAS PROVIDED IN E3 (INITIAL REPORTER OCCUPATION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY SUBMITTED IN ERROR IN THE INITIAL REPORT. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS USE RELATED PER CLINICAL DETAILS THAT ANGLE MATCHING WITH GAUZE SUPPORTING APPLIED RESOLVED THE OOZING.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE IMPELLA DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA RP FLEX DEVICE WAS INSERTED INTO THE RIGHT FEMORAL VEIN IN A 47-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY BYPASS GRAFT (CABG), PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK, IN SCAI STAGE E SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THERE WAS ACCESS SITE BLEEDING. THE SITE WAS UNDRESSED, ANGLE MATCHED, AND PRESSURE GAUZE APPLIED, WHICH RESOLVED THE OOZING. THE PHYSICIAN ALSO PLACED A FIGURE EIGHT SUTURE AND FLOW STAT TO HELP CONTROL THE BLEEDING. THE POST-PROCEDURE OUTCOME IS UNKNOWN. THE IMPELLA FUNCTIONED AT P-6 AT 2.0L/MIN 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
    64859 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026712331 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1