BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24782606 · Received April 3, 2026

    Report

    Report Number
    1220648-2026-06382
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 24, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS PLACED VIA DIRECT RIGHT SURGICAL AORTIC ACCESS IN A 69-YEAR-OLD MALE PATIENT UNDERGOING CORONARY ARTERY BYPASS GRAFT SURGERY WITH TWO GRAFTS. THE IMPELLA 5.5 WAS PLACED FOR TEMPORARY MECHANICAL CIRCULATORY SUPPORT IN THE PERIOPERATIVE SETTING. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS CONSISTENT WITH SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS SHOCK STAGE A. FOLLOWING CORONARY ARTERY BYPASS GRAFT SURGERY, THE PATIENT DEVELOPED SURGICAL BLEEDING AND COAGULOPATHY, WHICH WAS CONSISTENT WITH THE EXPECTED POSTOPERATIVE COURSE FOLLOWING OPEN CARDIAC SURGERY. THE PATIENT EXPERIENCED POSTOPERATIVE BLEEDING AND RECEIVED MULTIPLE BLOOD PRODUCT TRANSFUSIONS, INCLUDING PACKED RED BLOOD CELLS (PRBCS), FRESH FROZEN PLASMA (FFP), CRYOPRECIPITATE, AND PLATELETS. SYSTEMIC ANTICOAGULATION WAS NOT INITIATED AND REMAINED HELD DURING THIS PERIOD. BLEEDING IN THIS CLINICAL CONTEXT IS A KNOWN AND EXPECTED RISK ASSOCIATED WITH IMPELLA 5.5 SUPPORT, PARTICULARLY IN THE SETTING OF RECENT MAJOR CARDIAC SURGERY, DIRECT SURGICAL AORTIC ACCESS, PERIOPERATIVE COAGULOPATHY, AND CRITICAL ILLNESS. ADDITIONAL CONTRIBUTING FACTORS MAY INCLUDE LARGE-BORE ARTERIAL ACCESS, SURGICAL MANIPULATION, AND ONGOING TRANSFUSION REQUIREMENTS NECESSARY FOR HEMODYNAMIC MANAGEMENT. THE PATIENT WAS SUBSEQUENTLY TAKEN BACK TO THE OPERATING ROOM FOR SURGICAL WASHOUT AND EXPLORATION, DURING WHICH THE SOURCE OF BLEEDING WAS DETERMINED TO BE SURGICAL IN NATURE AND NOT RELATED TO THE IMPELLA GRAFT ANASTOMOSIS SITE. DURING THE POSTOPERATIVE COURSE, THE PATIENT ALSO DEVELOPED A GASTROINTESTINAL BLEED, CHARACTERIZED BY A PERSISTENT DECREASE IN HEMOGLOBIN AND HEMATOCRIT LEVELS AND DARK STOOLS. UPPER ENDOSCOPY DEMONSTRATED ESOPHAGEAL AND GASTROINTESTINAL EROSIONS. GASTROINTESTINAL BLEEDING CAN OCCUR AS A COMPLICATION IN CRITICALLY ILL POSTOPERATIVE CARDIAC SURGERY PATIENTS, PARTICULARLY IN THE SETTING OF STRESS-RELATED MUCOSAL INJURY, HYPOPERFUSION, COAGULOPATHY, AND PRIOR OR ANTICIPATED ANTICOAGULATION EXPOSURE REQUIRED FOR MECHANICAL CIRCULATORY SUPPORT. MANAGEMENT INCLUDED INTRAVENOUS PROTON PUMP INHIBITOR THERAPY, BLOOD TRANSFUSIONS, AND CONTINUED WITHHOLDING OF HEPARIN THERAPY. THE IMPELLA 5.5 DEVICE WAS SUBSEQUENTLY WEANED AND REMOVED. THE PATIENT TOLERATED THE IMPELLA WEAN WELL FROM A HEMODYNAMIC STANDPOINT, WITH NO REPORTED INSTABILITY DURING DEVICE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843679 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026780117 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention