BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24697619 · Received March 26, 2026

    Report

    Report Number
    1220648-2026-05919
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    March 21, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013344
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    A. PATIENT INFORMATION IS UNKNOWN. 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 NARRATIVE: PATIENT DEMOGRAPHICS ARE UNKNOWN. THE MEDICAL DOCTOR REPORTED THAT NO FOOT PULSES WERE PALPABLE IN THE AFFECTED LIMB, AND THE LEG APPEARED COLDER AND MOTTLED. HE RECOMMENDED CONSULTING THE CARDIOLOGIST OR VASCULAR SURGEON AND STATED HE WOULD CLARIFY THE SITUATION INTERNALLY. SUBSEQUENT UPDATES ON 21 MAR 2026 INDICATED THAT AN IMPELLA EXPLANTATION WAS ONGOING. LATER THE SAME DAY, IT WAS REPORTED THAT LIMB PERFUSION WAS RESTORED FOLLOWING DEVICE EXPLANT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE ON NOREPINEPHRINE. DUE TO LIMITED INFORMATION, SUCH AS PATIENT PAST MEDICAL HISTORY, ADMITTING CONDITION, COMORBIDITIES, AND SEVERAL ISCHEMIA RELATED PARAMETERS REMAIN UNKNOWN, THE EVENT WAS ATTRIBUTED TO THE DEVICE, AND THE PATIENT ULTIMATELY SURVIVED WITH RESTORATION OF PULSES AND SUCCESSFUL DEVICE WEANING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427183 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026791881 00813502013344

    Patients

    Seq Age Sex Outcome Treatment
    1