BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTO

    MDR report key: 24927168 · Received April 20, 2026

    Report

    Report Number
    3008011247-2026-00030
    Event Type
    Injury
    Date Received
    April 20, 2026
    Report Date
    March 24, 2026
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    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. 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 10.7759/CUREUS.95323 INTRODUCTION: LOW-PROFILE STENT GRAFTS WITH POLYMER RING SEALING TECHNOLOGY EXPANDED THE USE OF ENDOVASCULAR AORTIC REPAIR (EVAR) TO INCLUDE SHORT CONICAL NECKS AND SMALL ACCESS VESSELS IN GENERAL. WE EXAMINED THE USE OF THE ALTO STENT GRAFT (ENDOLOGIX LLC, IRVINE, CA) IN OUR REGIONAL VASCULAR CENTRE TO ASSESS ITS REAL-LIFE PERFORMANCE IN CASES DEEMED NOT SUITABLE FOR STANDARD STENTING. THIS WAS AN INDEPENDENT, SINGLE-CENTRE STUDY WITH NO FINANCIAL OR MATERIAL INVOLVEMENT FROM THE DEVICE MANUFACTURER. METHODS: THIS WAS A RETROSPECTIVE OBSERVATIONAL REVIEW OF ALL CONSECUTIVE PATIENTS TREATED WITH THE ALTO STENT GRAFT BETWEEN MAY 2020 AND JUNE 2024. PATIENT DEMOGRAPHICS, ANATOMICAL AND RADIOLOGICAL FEATURES, RE-INTERVENTIONS, AND GENERAL FOLLOW-UP DATA WERE COLLECTED. PRIMARY ENDPOINTS INCLUDED LONG-TERM SURVIVAL AND FREEDOM FROM TYPE IA ENDOLEAK. SECONDARY OUTCOMES INCLUDED SAC EXPANSION AND REINTERVENTIONS. RESULTS: FORTY-NINE PATIENTS WERE INCLUDED, OF WHOM 71.4% WERE NOT FIT FOR OPEN REPAIR. MEDIAN FOLLOW-UP WAS 48 MONTHS. HALF OF THE PATIENTS HAD A FLARED/CONICAL NECK, 20 PERCENT HAD SIGNIFICANT NECK THROMBUS, AND 30 PERCENT HAD A SMALL AORTIC BIFURCATION OR SMALL ILIAC VESSELS. THE MEDIAN LENGTH OF THE CONICAL/FLARED NECK WAS 10.5 MM (4-48 MM). MEDIAN MAXIMAL AORTIC NECK DIAMETER WAS 25.5 MM (19.5-31 MM). MEDIAN ILIAC ARTERY DIAMETER WAS 6.5 MM (4-9 MM). THE TECHNICAL SUCCESS RATE WAS 98 PERCENT, WITH ONLY ONE PATIENT CONVERTED TO OPEN. ONE PATIENT DIED WITHIN 30 DAYS AFTER DISCHARGE FROM CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)/COVID. FREEDOM FROM REINTERVENTION AT 12, 24, 36, AND 48 MONTHS WAS 100 PERCENT, 100 PERCENT, 100 PERCENT, AND 85.71 PERCENT, RESPECTIVELY. ONE PATIENT DEVELOPED A TYPE III ENDOLEAK AFTER FOUR YEARS. WE OBSERVED NO ANEURYSM RELATED MORTALITY. CONCLUSION: THE ALTO STENT-GRAFT SYSTEM DEMONSTRATES AN EFFECTIVE AND DURABLE SEAL IN ABDOMINAL AORTIC ANEURYSM (AAA) CASES WITH HOSTILE FEATURES, WITH OUTCOMES COMPARABLE TO STANDARD EVAR, EXPANDING THE OPTIONS FOR PATIENTS LESS FIT FOR OPEN REPAIR. WE OBSERVED NO ANEURYSM-RELATED MORTALITY, BUT OVERALL MORTALITY WAS 14%. ONE PATIENT DIED AT 30 DAYS (COVID-RELATED), FOUR WITHIN TWO YEARS, ONE DURING YEAR THREE, AND ONE DURING YEAR FOUR. A SINGLE-CENTRE STUDY - NO PATIENT IDENTIFIERS WERE COLLECTED, AND NO DIRECT PATIENT INVOLVEMENT OCCURRED. THE EXACT DATES OF THE STENT GRAFT IMPLANTATIONS AND THE ASSOCIATED EVENT(S) ARE UNKNOWN; HOWEVER, AN ENDOLOGIX ALTO STENT GRAFT SYSTEM WAS IMPLANTED BETWEEN MAY 01, 2020 AND JUNE 30, 2024. 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
    991505 ALTO MAIN BODY MIH ENDOLOGIX SANTA ROSA UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention OVATION IX ILIAC LIMB, LOT # UNKNOWN| OVATION IX ILIAC LIMB, LOT # UNKNOWN.