BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24574951 · Received March 11, 2026

    Report

    Report Number
    1220648-2026-05033
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    November 24, 2025
    Report Date
    May 19, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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

    UPDATED INFORMATION: D1 BRAND NAME UPDATED. D4 SERIAL NUMBER UPDATED. H6 COMPONENT CODE CHANGED TO G07003. THE INVESTIGATION FOR THE CARDIOGENIC SHOCK/RENAL FAILURE/ INFECTION/ ARRHYTHMIA/ HEMODYNAMIC INSTABILITY/MAJOR BLEED/ISCHEMIA/ORGAN FAILURE HAS BEEN COMPLETED. THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    A 61-YEAR-OLD MALE PATIENT WAS ADMITTED WITH ACUTE MI CARDIOGENIC SHOCK, OUT OF HOSPITAL CARDIAC ARREST. HE WAS PLACED ON VA ECMO AND INITIALLY SUPPORTED WITH AN IMPELLA CP (DIFFERENT CASE). HE WAS THEN TRANSFERRED AND IMPLANTED WITH AN IMPELLA 5.5. HE WAS CONVERTED TO VAV ECMO AND PLACED ON CONTINUOUS RENAL REPLACEMENT THERAPY FOR ACUTE KIDNEY INJURY. HE WAS 100% WITH A PACED RHYTHM AND HAD A PERMANENT PACEMAKER PLACED. THE PATIENT APPEARED TO BE SEPTIC WITH LOW SYSTEMIC VASCULAR RESISTANCE AND RISING WHITE BLOOD CELL COUNT, HOWEVER, BLOOD CULTURES WERE NEGATIVE. HE WAS TREATED WITH METHYLENE BLUE. HIS LACTATE, LIVER ENZYMES, AND CREATININE WERE CLIMBING CONFIRMING CARDIOGENIC SHOCK. HIS ABDOMEN AND LEFT LOWER EXTREMITY WERE TAUGHT WHICH REQUIRED FASCIOTOMY. HE RECEIVED BLOOD TRANSFUSIONS DUE TO DROPPING HEMATOCRIT. HE UNDERWENT ABOVE THE KNEE AMPUTATION ON (B)(6) 2025. THE PATIENT REQUIRED MULTIPLE VASOPRESSORS FOR ONGOING HYPOTENSION AND HEMODYNAMIC INSTABILITY. DUE TO ONGOING BLEEDING AT AMPUTATION SITE, MULTIPLE BLOOD PRODUCTS WERE REQUIRED. THE PATIENT WAS TRACHED ON (B)(6) 2025 AND CONTINUED TO HAVE SLOW CARDIAC RECOVERY. HE WAS EXPLANTED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612384 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026729465 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention