BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION IX

    MDR report key: 25306716 · Received May 27, 2026

    Report

    Report Number
    3008011247-2026-00043
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ADVERSE EVENT/INCIDENT WAS INVESTIGATED IN ALIGNMENT WITH ENDOLOGIX OPERATING PROCEDURES AND WORK INSTRUCTIONS. THE REPORTED ADVERSE EVENT/INCIDENT WAS IDENTIFIED BY ENDOLOGIX THROUGH AN ONGOING REVIEW OF INDUSTRY RELEVANT JOURNAL ARTICLES WHERE PATIENT RELATED OUTCOMES ARE PRESENTED ANONYMOUSLY, AND PATIENT SPECIFIC DEVICE INFORMATION IS UNAVAILABLE. DUE TO THE ANONYMISED AND LIMITED NATURE OF INFORMATION AVAILABLE FROM THE LITERATURE SOURCE, A DETAILED INVESTIGATION COULD NOT BE PERFORMED. DEVICE SPECIFIC INFORMATION, INCLUDING DEVICE IDENTIFICATION, PROCEDURAL DETAILS, AND PATIENT CHARACTERISTICS, IS NOT PROVIDED; THEREFORE, MANUFACTURING RECORD REVIEW, DEVICE EVALUATION, AND A COMPREHENSIVE CLINICAL ASSESSMENT COULD NOT BE CONDUCTED. IN THE ABSENCE OF CASE SPECIFIC DATA, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. HOWEVER, BASED ON THE REPORTED INFORMATION AND IN ACCORDANCE WITH A CONSERVATIVE VIGILANCE APPROACH, A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED INCIDENT CANNOT BE EXCLUDED. THE INCIDENT HAS BEEN ASSESSED WITHIN THE CONTEXT OF ENDOLOGIX POST MARKET SURVEILLANCE ACTIVITIES, INCLUDING EVALUATION OF SIMILAR REPORTED INCIDENTS, KNOWN DEVICE RELATED RISKS, AND COMPLAINT TREND DATA, TO SUPPORT ONGOING MONITORING AND SIGNAL DETECTION. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT COULD NOT BE COMPLETED AS THE REPORTED EVENT WAS FOUND DURING PUBLICATION REVIEW WHERE THE PATIENT INFORMATION IS ANONYMOUS. DEVICE, USE, PROCEDURE, AND/OR ANATOMY RELATEDNESS TO THIS ADVERSE EVENT/INCIDENT COULD NOT BE EVALUATED. NO ADDITIONAL INVESTIGATION OF THIS REPORTED ADVERSE EVENT/INCIDENT IS PLANNED. HOWEVER, SHOULD ADDITIONAL INFORMATION RELEVANT TO THE INVESTIGATION OUTCOME BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS AND SIMILAR ADVERSE EVENTS/INCIDENTS. H3 OTHER TEXT: DEVICE LOCATION NOT REPORTED.

    Description of Event or Problem · 0

    THE REPORTED INCIDENT WAS IDENTIFIED BY ENDOLOGIX THROUGH A RETROSPECTIVE REVIEW OF AN INDUSTRY RELEVANT ABSTRACT IN JOURNAL OF VASCULAR SURGERY ABSTRACTS E133 VOLUME 82, NUMBER 4: 29 CSVS 2025. OBJECTIVE: THIS STUDY EVALUATED SHORT- AND LONG-TERM CLINICAL OUTCOMES OF THREE GENERATIONS OF ENDOLOGIX POLYMER-FILLED STENT GRAFTS USED FOR ENDOVASCULAR ANEURYSM REPAIR (EVAR) IN PATIENTS WITH HOSTILE AORTIC ANATOMY, FOCUSING SPECIFICALLY ON MORTALITY, PATENCY RATES, AND REINTERVENTION REQUIREMENTS. METHODS: THIS RETROSPECTIVE COHORT ANALYSIS INCLUDED ALL PATIENTS WHO UNDERWENT EVAR USING ENDOLOGIX POLYMER-FILLED STENT GRAFTS AT OUR INSTITUTION BETWEEN JANUARY 2015 AND DECEMBER 2024. OVER 800 EVAR PROCEDURES WERE PERFORMED DURING THIS PERIOD, WITH ENDOLOGIX GRAFTS SELECTED FOR PATIENTS PRESENTING CHALLENGING ANATOMICAL CONDITIONS SUCH AS HOSTILE PROXIMAL NECK ANATOMY OR SMALL ACCESS VESSELS. RESULTS: IN TOTAL, 106 PATIENTS (MEAN AGE, 76.3 YEARS; 80 PERCENT MALE) RECEIVED POLYMER-FILLED STENT GRAFTS. A HISTORY OF HYPERTENSION AND SMOKING WAS PREVALENT IN 84 PERCENT AND 90 PERCENT OF CASES, RESPECTIVELY. HOSTILE PROXIMAL NECK ANATOMY WAS THE PRIMARY INDICATION FOR GRAFT USE. THE MEAN HOSPITAL STAY WAS 4.2 6 4.3 DAYS. MAJOR POSTOPERATIVE COMPLICATIONS WERE RARE, INCLUDING PULMONARY EVENTS (3 PERCENT), ACUTE KIDNEY FAILURE (3 PERCENT), ARRHYTHMIAS (2 PERCENT), AND INGUINAL HEMATOMAS (4 PERCENT). OVER AN AVERAGE FOLLOW-UP OF 38. MONTHS, 27 PERCENT OF PATIENTS REQUIRED REINTERVENTION, MAINLY FOR ENDOLEAKS (13 TYPE 1A, 10 TYPE 2), GRAFT STENOSIS OR OCCLUSION (7 CASES), WOUND DEHISCENCE (2 CASES), AND EXPLANTS (2 CASES). PRIMARY PATENCY RATES WERE 90 PERCENT AT 1 YEAR AND 88 PERCENT AT 5 YEARS, WITH SECONDARY PATENCY AT 5 YEARS REACHING 98 PERCENT. SURVIVAL RATES AT 1, 5, AND 7 YEARS WERE 98 PERCENT, 77 PERCENT, AND 55 PERCENT, RESPECTIVELY. CONCLUSIONS: EVAR USING ENDOLOGIX POLYMER-FILLED STENT GRAFTS DEMONSTRATED ENCOURAGING LONG-TERM SURVIVAL AND PATENCY IN PATIENTS WITH COMPLEX ANATOMY. THE FREQUENT OCCURRENCE OF ENDOLEAKS AND REINTERVENTIONS UNDERSCORES PROCEDURAL COMPLEXITY. DESPITE THESE CHALLENGES, EXCELLENT SECONDARY PATENCY AND SURVIVAL OUTCOMES HIGHLIGHT THE GRAFTS¿ VALUE, PARTICULARLY WHERE TRADITIONAL GRAFTS ARE UNSUITABLE. FURTHER RESEARCH IS ESSENTIAL TO OPTIMIZE PATIENT SELECTION AND OUTCOMES. THE EXACT DATES OF THE STENT GRAFT IMPLANTATION(S) AND THE DATE(S) OF THE REPORTED EVENT(S) WERE NOT PROVIDED IN THE ARTICLE. BASED ON THE AVAILABLE INFORMATION, IMPLANTATION(S) AND THE REPORTED EVENT(S) OCCURRED BETWEEN JANUARY 2015 AND DECEMBER 2024. NO INFORMATION WAS PROVIDED REGARDING DEVICE LOT NUMBER, SERIAL NUMBER, SIZING, PROCEDURAL TECHNIQUE, IMAGING FINDINGS, OR DEVICE CONDITION. PATIENT OUTCOME FOLLOWING THE ADDITIONAL INTERVENTION WAS NOT REPORTED, AND NO DEATH WAS REPORTED IN THE PUBLICATION. DUE TO THE LIMITED INFORMATION AVAILABLE FROM THE LITERATURE SOURCE, A CAUSAL RELATIONSHIP BETWEEN THE ENDOLOGIX OVATION PRIME, OVATION IX, AND ALTO ENDOVASCULAR STENT GRAFT DEVICES AND THE REPORTED EVENT CANNOT BE DETERMINED, AND THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44492 OVATION IX MAIN BODY MIH ENDOLOGIX SANTA ROSA UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1