BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION

    MDR report key: 24901819 · Received April 16, 2026

    Report

    Report Number
    3008011247-2026-00029
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Report Date
    March 23, 2026
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE COMPLETED. THE PART NUMBER/LOT NUMBER COMBINATION NEEDED FOR DEVICE IDENTIFICATION REMAINS UNKNOWN. AN EVALUATION OF THE DEVICE COULD NOT BE COMPLETED. THE DEVICE WAS NOT RETURNED TO ENDOLOGIX FOR EVALUATION. 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. (B)(4).

    Description of Event or Problem · 0

    THE REPORTED INCIDENT WAS IDENTIFIED BY ENDOLOGIX THROUGH REVIEW OF AN INDUSTRY RELEVANT JOURNAL ARTICLE. DOI: 10.7759/CUREUS.93970. BACKGROUND: ENDOVASCULAR ANEURYSM REPAIR (EVAR) IS A WIDELY USED, MINIMALLY INVASIVE ALTERNATIVE MANAGEMENT OPTION TO OPEN SURGICAL REPAIR FOR INFRARENAL ABDOMINAL AORTIC ANEURYSMS (INFRARENAL AAAS). HOWEVER, STANDARD STENT GRAFTS HAVE THEIR CHALLENGES FOR COMPLEX AORTIC ANATOMIES. THE OVATION ABDOMINAL STENT GRAFT SYSTEM (ENDOLOGIX INC., SANTA ROSA, CA), WHICH IS A POLYMER-FILLED SEALING RING ENDOGRAFT, HAS EMERGED AS A PROMISING SOLUTION FOR PATIENTS WITH CHALLENGING ANATOMICAL FEATURES. THIS STUDY AIMS TO EVALUATE THE TECHNICAL SUCCESS, EFFECTIVENESS, AND LONG-TERM OUTCOMES, INCLUDING REINTERVENTION AND SURVIVAL, OF THE OVATION SYSTEM IN TREATING COMPLEX INFRARENAL AAAS. METHODS: WE CONDUCTED A SINGLE-CENTRE, RETROSPECTIVE OBSERVATIONAL STUDY OF 103 PATIENTS WITH ANATOMICALLY CHALLENGING INFRARENAL AAAS TREATED WITH THE OVATION STENT GRAFT BETWEEN (B)(6) 2015 AND (B)(6) 2017 IN A UK-BASED TERTIARY CENTRE. ANATOMICAL PARAMETERS INCLUDED SHORT NECKS, SEVERE ANGULATION (GREATER60°), SIGNIFICANT THROMBUS OR CALCIFICATION (GREATER180° OF THE WALL DIAMETER), NON-CYLINDRICAL NECK SHAPES, OR AN ILIAC ACCESS DIAMETER <6 MM. OUTCOMES ASSESSED INCLUDED TECHNICAL PROCEDURAL SUCCESS, ENDOLEAK INCIDENCE, CONVERSION TO OPEN REPAIR, REINTERVENTION RATES, 30-DAY ANEURYSM-RELATED MORTALITY, AND ALL-CAUSE MORTALITY OVER A 5-YEAR FOLLOW-UP. RESULTS: A TOTAL OF 103 PATIENTS UNDERWENT EVAR USING THE OVATION STENT GRAFT BETWEEN JANUARY 2015 AND NOVEMBER 2017, WITH A 5-YEAR FOLLOW-UP. ALL PATIENTS HAD AT LEAST ONE ADVERSE ANATOMICAL FEATURE, INCLUDING SHORT NECKS, SIGNIFICANT THROMBUS OR CALCIFICATION, SEVERE NECK ANGULATION, OR NARROW ILIAC ACCESS. THE COHORT WAS PREDOMINANTLY MALE, COMPRISING 80 PATIENTS (77.7PERCENT), WITH A MEAN AGE OF 76.4 YEARS (SD = 6.67). TECHNICAL SUCCESS WAS ACHIEVED IN 97PERCENT OF CASES, WITH TYPE I ENDOLEAK OBSERVED INTRAOPERATIVELY IN 3 PATIENTS (2.9PERCENT). INTRAOPERATIVE COMPLICATIONS OCCURRED IN 4.8PERCENT OF PATIENTS, WITH NO ANEURYSM RUPTURE OR CONVERSIONS TO OPEN SURGERY. THE 30-DAY ANEURYSM-RELATED MORTALITY WAS 0%, AND THE OVERALL REINTERVENTION RATE OVER FIVE YEARS WAS 9.7 PERCENT. THE FIVE-YEAR ALL-CAUSE MORTALITY RATE WAS 16.5PERCENT. CONCLUSIONS: THE OVATION POLYMER-BASED ENDOGRAFT DEMONSTRATES EXCELLENT TECHNICAL SUCCESS AND FAVOURABLE LONG-TERM OUTCOMES IN PATIENTS WITH INFRARENAL AAA WITH UNFAVOURABLE ANATOMY, INCLUDING LOW RATES OF TYPE I ENDOLEAKS, REINTERVENTION, AND ANEURYSM-RELATED MORTALITY. THESE FINDINGS SUPPORT ITS USE AS A DURABLE AND EFFECTIVE EVAR SOLUTION IN ANATOMICALLY CHALLENGING CASES BEYOND THE STANDARD IFU. FURTHER MULTICENTRE PROSPECTIVE STUDIES ARE WARRANTED TO CONFIRM THESE PROMISING RESULTS. THE EXACT DATES OF THE STENT GRAFT IMPLANTATIONS AND THE ASSOCIATED EVENT(S) ARE UNKNOWN; HOWEVER, AN ENDOLOGIX OVATION PLATFORM, (OVATION, OVATION PRIME, AND OVATION IX ABDOMINAL STENT GRAFT SYSTEMS ITERATION IS UNKNOWN) WAS IMPLANTED BETWEEN (B)(6) 2015 AND (B)(6) 2017. THE EVENT DATE(S), SPECIFIC EVENT DETAILS, LOT NUMBERS, AND CATALOG NUMBERS ARE UNKNOWN. NO ADDITIONAL INFORMATION IS EXPECTED TO BECOME AVAILABLE FOR THIS REPORT DUE TO THE ABSENCE OF PATIENT IDENTIFIERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964276 OVATION MAIN BODY MIH ENDOLOGIX SANTA ROSA UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other OVATION ILIAC LIMB: LOT# UNKNOWN| OVATION ILIAC LIMB: LOT# UNKNOWN