BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

    MDR report key: 24799369 · Received April 7, 2026

    Report

    Report Number
    1220648-2026-06449
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    November 20, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: ROM, A., ANASTASIOU, A., GIATAGANTZIDOU, I., YALDIZLI, Ö., BOEDDINGHAUS, J., PSYCHOGIOS, M.-N., & TUCHSCHERER, D. T. (2026). SPINAL ISCHEMIA AFTER PROLONGED RESUSCITATION AND CORONARY ANGIOGRAPHY UNDER IMPELLA PROTECTION. EUROPEAN JOURNAL OF CASE REPORTS IN INTERNAL MEDICINE, 13(2). HTTPS://DOI.ORG/10.12890/2026_006023 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: AN IMPELLA RELATED PUBLICATION WAS DISCOVERED WHICH DETAILS THE IMPELLA SUPPORT OF A 46 YEAR OLD FEMALE. THE PATIENT HAS SUFFERED A VENTRICULAR FIBRILLATION CARDIAC ARREST AND GIVEN CARDIAC COMPRESSION BY MEDICAL EMERGENCY SERVICES. THE PATIENT WAS TAKEN TO THE MEDICAL CENTER AND CARDIAC CATHETERIZATION LAB. THE IMPELLA WAS PLACED TO ALLOW FOR HEMODYNAMIC SUPPORT DURING CARDIAC INTERVENTION. IMMEDIATELY AFTER THE INTERVENTION THE TEAM EXPLANTED THE PUMP DUE TO LIMB ISCHEMIA. THE PATIENT WAS THEN SENT TO THE ICU FOR MONITORING. THE PATIENT WAS SEEN TO HAVE PARAPLEGIA AND INFARCTS. THE PATIENT DID SURVIVE AND WAS SENT TO A REHABILITATION CENTER AFTER 19 DAYS IN THE ICU. THE PATIENT DID SURVIVE, BUT NEUROLOGICAL COMPLICATIONS REMAINED. LIMB ISCHEMIA MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS SEVERE PERIPHERAL VASCULAR DISEASE, UNDERLYING CRITICAL ILLNESS, HEMODYNAMIC INSTABILITY, AND VASCULAR ACCESS CHARACTERISTICS. THE PATIENT SPECIFICS AND UNDERLYING MEDICAL HISTORY WERE NOT SHARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265051 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1