BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION

    MDR report key: 24889906 · Received April 15, 2026

    Report

    Report Number
    3008011247-2026-00024
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Report Date
    March 18, 2026
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE REPORTED INCIDENT WAS IDENTIFIED BY ENDOLOGIX THROUGH REVIEW OF AN INDUSTRY RELEVANT JOURNAL ARTICLE. DOI.ORG/10.3390/JCM14124177. ABSTRACT: BACKGROUND/OBJECTIVE: TO REPORT MID-TERM TO LONG-TERM OUTCOME DATA FOR ENDOVASCULAR AORTIC REPAIR USING THE OVATION STENT GRAFT SYSTEM (ENDOLOGIX, SANTA ROSA, CA) FOR THE CORRECTION OF ABDOMINAL AORTIC ANEURYSMS (AAAS) IN A SINGLE CENTER. METHODS: ALL PATIENTS TREATED WITH THE OVATION STENT GRAFT BETWEEN DECEMBER 2011 AND FEBRUARY 2018 WERE INCLUDED. PATIENT DEMOGRAPHICS, ANATOMICAL AND OPERATIVE DETAILS, AS WELL AS FOLLOW- UP DATA INCLUDING COMPLICATIONS, THE NEED FOR FURTHER INTERVENTIONS, AND MORTALITY WERE RECORDED PROSPECTIVELY IN AN ELECTRONIC DATASET AND ANALYZED. RESULTS: A TOTAL OF 99 PATIENTS (86.10 PERCENT MALES; MEAN AGE 73.6 TO 7.26 YEARS) WERE TREATED WITH THE OVATION STENT GRAFT. THE MEAN MAXIMAL AORTIC DIAMETER WAS 53.7 MM TO 8.8 MM. THE MAIN INDICATIONS FOR OVATION USE WERE SMALL ILIAC ACCESSES AND THROMBUS/CALCIFICATION AT THE PROXIMAL NECK LEVEL. THE TECHNICAL SUCCESS RATE WAS 93.06 PERCENT. NO PERIOPERATIVE REINTERVENTION OR LIMB OCCLUSION WAS REPORTED. TWO GRAFT-RELATED PERIOPERATIVE ADVERSE EVENTS WERE RECORDED. AT A MEAN FOLLOW UP OF 82.70 PERCENT AT 40 MONTHS, CUMULATIVE LATE SURVIVAL WAS 97.90 PERCENT, 92.60 PERCENT, 81.00 PERCENT, 73.40 PERCENT, 48.70 PERCENT, AND 45.10 PERCENT, RESPECTIVELY, AT 12, 24, 48, 60, 108, AND 120 MONTHS. NO AAA-RELATED DEATH WAS RECORDED. ACTUARIAL FREEDOM FROM REINTERVENTION RATE WAS 97.90 PERCENT, 95.70 PERCENT, 92.10 PERCENT, AND 80.10 PERCENT, RESPECTIVELY, AT 12, 24, 60, 108, AND 120 MONTHS; ESTIMATED FREEDOM FROM CONVERSION WAS 98.90 PERCENT, 97.70 PERCENT, AND 95.20 PERCENT AT 24, 60, 108, AND 120 MONTHS. CONCLUSIONS: THE OVATION STENT GRAFT DEMONSTRATED DURABLE AAA EXCLUSION EVEN IN COMPLEX ANATOMIES EVIDENCED BY SUCCESSFUL ANEURYSM EXCLUSION AND MID- TO LONGTERM FREEDOM FROM ANEURYSM-RELATED MORTALITY. HOWEVER, IN THIS SERIES, THE NOT INSIGNIFICANT GRAFT-RELATED ADVERSE EVENT RATE SUGGESTED THE NEED FOR STRUCTURAL IMPROVEMENTS, WHICH WERE IMPLEMENTED IN THE NEXT-GENERATION DEVICES. 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 DECEMBER 2011 AND FEBRUARY 2018. 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
    949858 OVATION MAIN BODY MIH ENDOLOGIX SANTA ROSA UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention BARE METAL STENT (NON-ENDOLOGIX)| COVERED BALLOON EXPAND STENT NUMED (NONENDOLOGIX)| ENDURANT STENT GRAFT (NON-ENDOLOGIX)| OFF-THE-SHELF BRANCHED ENDOGRAFT(NON-ENDOLOGIX)| OVATION ILIAC LIMB: LOT NUMBER UNKNOWN| OVATION ILIAC LIMB: LOT NUMBER UNKNOWN