BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24615742 · Received March 17, 2026

    Report

    Report Number
    1220648-2026-05408
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    March 3, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D1 MAJOR BLEED/PERI-PROCEDURAL ADVERSE EVENT: THE CAUSE OF THE ISSUE WAS NOT ESTABLISHED AS LIMITED CLINICAL INFORMATION WAS PROVIDED HEMOLYSIS: THE CAUSE OF THE ISSUE WAS LIKELY PATIENT CONDITION RELATED AS CLINICAL INFORMATION MENTIONED HEMOLYSIS WHICH RESOLVED WITH VOLUME.

    Additional Manufacturer Narrative · 0

    D4: CORRECTED THE UDI.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D4 (SERIAL NUMBER). CORRECTED INFORMATION WAS PROVIDED IN D3 AND G1 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT THESE WERE INADVERTENTLY OMITTED FROM THE INITIAL REPORT. 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

    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 RATIONALE: AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT DIRECT SURGICAL APPROACH IN A 67-YEAR-OLD MALE PATIENT PRESENTING FOR ELECTIVE PLACEMENT, SCAI SHOCK STAGE A, WITH A HISTORY OF KNOWN CORONARY ARTERY DISEASE. THE PATIENT UNDERWENT CABG × 1, MITRAL VALVE REPLACEMENT, LEFT ATRIAL APPENDAGE (LAA) CLIP, AND MAZE PROCEDURE ALONG WITH DIRECT IMPELLA 5.5 IMPLANTATION. THE IMPLANT PROCEEDED PER THE INSTRUCTIONS FOR USE (IFU). THE PATIENT REQUIRED 2 UNITS OF FRESH FROZEN PLASMA AND 2 UNITS OF PLATELETS DUE TO COAGULOPATHY. THE DEVICE WAS LATER EXPLANTED, AND HEMOLYSIS RESOLVED WITH VOLUME ADMINISTRATION. THE PATIENT SURVIVED TO EXPLANT. THE REPORTED BLEEDING REQUIRING BLOOD PRODUCT TRANSFUSION IS CONSISTENT WITH PERIOPERATIVE AND ACCESS-RELATED COMPLICATIONS IN THE CONTEXT OF SURGICAL AXILLARY PLACEMENT AND THE ANTICOAGULATION/PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT. THE REPORTED HEMOLYSIS MAY BE INFLUENCED BY PERIOPERATIVE FACTORS SUCH AS HEMODILUTION, NATIVE CARDIAC DYSFUNCTION, AND THE HEMODYNAMIC INSTABILITY ASSOCIATED WITH CARDIAC SURGERY AND MECHANICAL CIRCULATORY SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109180 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026620586 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1