BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVANTA V12 COVERED STENT

    MDR report key: 24530697 · Received March 6, 2026

    Report

    Report Number
    3011175548-2026-000002
    Event Type
    Death
    Date Received
    March 6, 2026
    Report Date
    May 2, 2026
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    NIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SECTION: H6. CORRECTED FIELD: D2. RELATED MDR 3011175548-2026-0000021. THIS INVESTIGATION REVIEWED A RETROSPECTIVE CLINICAL ARTICLE ANALYZING ENDOVASCULAR PROCEDURES PERFORMED BETWEEN 2012 AND 2020 AT A SINGLE INSTITUTION. THE ARTICLE REPORTED OUTCOMES FOR VISCERAL ARTERY STENTING PROCEDURES INVOLVING MULTIPLE DEVICES, INCLUDING THE ADVANTA V12 COVERED STENT SYSTEM. DURING THE STUDY PERIOD, USE OF THE ADVANTA V12 IN THE SUPERIOR MESENTERIC ARTERY AND CELIAC ARTERY WOULD HAVE BEEN CONSIDERED OFF LABEL, AS THE APPROVED INDICATIONS AT THAT TIME WERE LIMITED TO ILIAC AND RENAL ARTERIES. THE ARTICLE DOCUMENTED TWO DEATHS AMONG 96 PATIENTS, ONE ASSOCIATED WITH SMA STENT OCCLUSION AND ONE DUE TO IATROGENIC CELIAC ARTERY DISSECTION WITH SUBSEQUENT THROMBOSIS. THE PUBLICATION DID NOT IDENTIFY THE SPECIFIC STENT INVOLVED IN EITHER DEATH. BOTH EVENTS OCCURRED IN THE CONTEXT OF COMPLEX VASCULAR INTERVENTIONS, AND SIMILAR COMPLICATIONS WERE REPORTED WITH DIFFERENT STENT PLATFORMS USED IN THE STUDY. NO PRODUCT IDENTIFICATION INFORMATION WAS AVAILABLE, PREVENTING DHR REVIEW OR MANUFACTURING ASSESSMENT. COMPLAINT TRENDING DATA FROM THE MOST RECENT 15 MONTH PERIOD DID NOT IDENTIFY A SIGNAL REQUIRING CAPA ESCALATION, AND NO SIMILAR ARTICLE COMPLAINTS HAVE BEEN RECEIVED DURING THAT TIMEFRAME. RISK MANAGEMENT REVIEW CONFIRMED THAT THE REPORTED HAZARD AND HARM OCCLUSION EMBOLISM RESULTING IN DEATH ARE ALREADY ADDRESSED WITHIN THE PRODUCT RISK FILES, WITH APPROPRIATE SEVERITY AND OCCURRENCE LEVELS. BASED ON THE AVAILABLE EVIDENCE, NO RELATIONSHIP BETWEEN THE ADVANTA V12 DEVICE AND THE REPORTED PATIENT DEATHS COULD BE ESTABLISHED. THE MOST LIKELY ROOT CAUSE IS ATTRIBUTED TO CLINICAL AND OPERATIONAL FACTORS INHERENT TO COMPLEX ENDOVASCULAR PROCEDURES AND PATIENT SPECIFIC CONDITIONS, RATHER THAN A DEVICE RELATED FAILURE. ACCORDINGLY, THE ARTICLE COMPLAINT CANNOT BE CONFIRMED, AND NO CORRECTIVE OR PREVENTIVE ACTIONS ARE WARRANTED.

    Description of Event or Problem · 0

    AN ARTICLE/LITERATURE WAS RECEIVED AND REVIEWED: MIDTERM PERFORMANCE OF BRIDGING STENT-GRAFTS USED FOR VISCERAL BRANCHES IN FENESTRATED ENDOVASCULAR ANEURYSM REPAIR. BACKGROUND: FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (FEVAR) FOR COMPLEX ANEURYSMS IS A WELL-ESTABLISHED TREATMENT REQUIRING THE USE OF BRIDGING COVERED STENTS TO MAINTAIN PERFUSION TO THE VISCERAL ORGANS. LONG-TERM PATENCY IS THREATENED BY VARIED COMPLICATIONS INCLUDING STENOSIS, OCCLUSION, AND/OR ENDOLEAK. THESE COMPLICATIONS ARE COLLECTIVELY TERMED ¿¿TARGET ARTERY INSTABILITY¿¿ (TAI). HERE, WE REPORT RATES OF TAI AND THE MIDTERM OUTCOMES OF BRIDGING STENTS USED IN FEVAR PROCEDURES IN A SINGLE CENTER. METHODS: IT IS A RETROSPECTIVE STUDY. CONSECUTIVE PATIENTS UNDERGOING FEVAR BETWEEN 2012 AND 2020 WERE ANALYZED RETROSPECTIVELY. TAI FOR ALL BALLOON-EXPANDABLE COVERED STENTS MATED WITH REINFORCED FENESTRATIONS WAS ASSESSED. RESULTS: NINETY-SIX PATIENTS (95% MEN, MEDIAN AGE 75) WERE TREATED WITH FEVAR. EIGHTY-NINE ANEURYSMS WERE JUXTARENAL, 7 FOR MORE PROXIMAL THORACOABDOMINAL ANEURYSMS. A TOTAL OF 268 BRIDGING STENTS WERE USED (14 CELIAC, 78 IN SUPERIOR MESENTERIC ARTERY [SMA], 176 RENAL). THE MEDIAN FOLLOW-UP WAS 51 MONTHS (INTERQUARTILE RANGE 36E81). TAI OCCURRED IN 4.9% (N ¼ 13) STENTED VESSELS, WITH 7 OCCLUSIONS, 5 ENDOLEAKS, AND 1 ARTERY PERFORATION. EIGHT PATIENTS REQUIRED REINTERVENTION, WITH 2 DEATHS (1 FROM DISSECTION OF A CELIAC VESSEL AND 1 SMA STENT OCCLUSION); 2 PATIENTS REQUIRED LONG-TERM DIALYSIS FROM THE LOSS OF PERFUSION TO A SINGLE KIDNEY. OVERALL, FREEDOM FROM TAI WAS 97% AT 3 YEARS AND 95% AT 5 YEARS. PER THE ARTICLE A DEATH OCCURRED FROM SMA STENT OCCLUSION.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366730 ADVANTA V12 COVERED STENT STENT, ILIAC NIO ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death