BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24618441 · Received March 17, 2026

    Report

    Report Number
    1220648-2026-05442
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    March 10, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    ADDITIONAL INFORMATION WAS RECEIVED, SPECIFICALLY THE RETURN OF THE DEVICE, AND EVALUATION/ANALYSIS IS CURRENTLY IN PROGRESS. ACCORDINGLY, SECTION D9 HAS BEEN UPDATED TO REFLECT THE DEVICE RECEIPT DATE. SECTION H6 (INVESTIGATION TYPE, FINDINGS, AND CONCLUSION) HAS ALSO BEEN UPDATED TO ALIGN WITH THIS INFORMATION. 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 WERE PROVIDED IN D1 AND D4. UPON REVIEW, THE BRAND NAME AND SERIAL NUMBER HAVE BEEN UPDATED. CORRECTED INFORMATION WERE PROVIDED IN D3, E1 (INITIAL REPORTER TITLE), AND G1 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT THESE WERE INADVERTENTLY OMITTED FROM THE INITIAL REPORT. UPDATED H3 TO 'YES' AS THE DEVICE WAS RECEIVED AND EVALUATED. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF MAJOR BLEED/ACCESS SITE ADVERSE EVENT WAS MOST LIKELY USE RELATED SINCE THE CLINICAL TEAM CONFIRMED THE BLEEDING WAS DUE TO THE PATIENT TRIED TO SIT UP ON PROCEDURE TABLE AND IMPELLA SITE STARTED BLEEDING BRISKLY.

    Description of Event or Problem · 0

    CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS INSERTED VIA RIGHT FEMORAL ARTERY IN A 62 YEAR OLD MALE FOR PRE-OPERATIVE PLACEMENT. THE PATIENT HAD AN ELEVATED END-DIASTOLIC PRESSURE OF 39 AND MULTI-VESSEL CORONARY ARTERY DISEASE. THE PATIENT¿S COMORBIDITIES INCLUDED CORONARY ARTERY DISEASE, DIABETES MELLITUS, HYPERTENSION, HYPERLIPIDEMIA, MODERATE CARDIOMYOPATHY AND MILD PULMONARY EDEMA. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE A. AT THE START OF THE PROCEDURE, THE PATIENT TOLERATED CP PLACEMENT WITHOUT ISSUE AND WAS ALERT AND ORIENTED. AFTER SWAN PLACEMENT AND DURING CP DRESSING, THE PATIENT ATTEMPTED TO SIT UP ON THE PROCEDURE TABLE, IN WHICH THE IMPELLA SITE STARTED BLEEDING. MANUAL PRESSURE WAS APPLIED FOR OVER 40 MINUTES AND BEST PRACTICES PERFORMED FOR ANGLE MATCHING, HOWEVER BLEEDING CONTINUED. THE PATIENT'S ACTIVATED CLOTTING TIME WAS 194 AND HEPARIN WAS NOT YET STARTED. A FIGURE 8 SUTURE WAS PLACED AT THE INSERTION SITE, YET BLEEDING CONTINUED. DUE TO THE PATIENT BECOMING AGITATED AND NON-COMPLIANT WITH INSTRUCTIONS, IT WAS DECIDED TO EXPLANT THE DEVICE. IT IS ALSO REPORTED THERE WAS A LANGUAGE BARRIER FOR THE PATIENT. THE CP WAS EXPLANTED SUCCESSFULLY AND SITE CLOSED WITH 3 PERCLOSE AND MANUAL PRESSURE TO ACHIEVE HEMOSTASIS. THERE WAS NO ADDITIONAL BLEEDING OR HEMATOMA AT THE TIME OF TRANSFER TO THE INTENSIVE CARE UNIT. THE BLEEDING MAY OCCUR IN THE SETTING OF IMPELLA CP SUPPORT AND VASCULAR SITE ACCESS, AND MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS THE UNDERLYING CARDIOGENIC SHOCK PHYSIOLOGY, HEMODYNAMIC INSTABILITY, AND DEVICE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57016 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026713848 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1