BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24727197 · Received March 30, 2026

    Report

    Report Number
    1220648-2026-06098
    Event Type
    Death
    Date Received
    March 30, 2026
    Date of Event
    March 21, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    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

    B1/B2 REQUIRED INTERVENTION WAS SELECTED AS IT WAS OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED. D4 CATALOG, SERIAL AND PRIMARY UDI NUMBER WERE REVISED. H6 COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS WERE UPDATED ACCORDINGLY BASED ON INVESTIGATION FINDINGS. H11 THE IMPELLA DEVICE WAS NOT RETURNED, AND THE INVESTIGATION HAS BEEN COMPLETED. INVESTIGATION SUMMARY - MAJOR BLEED/ACCESS SITE ADVERSE EVENT: THE CAUSE OF MAJOR BLEED/ACCESS SITE ADVERSE EVENT WAS MOST LIKELY PATIENT CONDITION RELATED SINCE THE BLEEDING OCCURRED AT ALL SITES & THE PHYSICIAN CONFIRMED THE PATIENT HAD DIC. HYPOTENSION: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA RP FLEX WAS INSERTED VIA THE FEMORAL VEIN TO SUPPORT THE 74-YEAR-OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK. THE PATIENT'S MEDICAL HISTORY WAS KNOWN TO BE INCLUSIVE OF BIVENTRICULAR FAILURE AND AS SUCH THE LEFT HEART HAD AN IMPELLA CP SUPPORT ONGOING. THE PATIENT HAS KNOWN RENAL HISTORY AND IS AWAITING KIDNEY TRANSPLANT. PRIOR TO THE RP FLEX BEING PLACED THE HEMOGLOBIN WAS 7.9G/DL AND HEPARIN BOLUS WAS NOT GIVEN DESPITE THE PTT BEING 55. THE CP AND RP FLEX WERE INSERTED AND PATIENT SENT TO THE ICU FOR CONTINUED MONITORING. HEPARIN WAS GIVEN LATER WHEN IN THE ICU. WHEN IN THE ICU THE GROIN ACCESS SITE WAS SEEN TO HAVE A BLEED. IN THE ICU THE PATIENT CONDITION DETERIORATED, THE PATIENT WAS HYPOTENSIVE AND THE ACCESS SITE WAS OOZING AND BLOOD PRODUCTS WERE GIVEN, MANUAL PRESSURE HELD, AND HEPARIN PUT ON HOLD. THE PATIENT EXPIRED AFTER THE 26 HOUR SUPPORT. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING. THE CAUSE OF DEATH WAS NOT SHARED AND BOTH THE ACCESS SITES OF THE CP AND RP FLEX WERE KNOWN TO BE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400357 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026795500 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1