BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA V12,COVERED STENTSYS, 9X59X120

    MDR report key: 24034881 · Received January 12, 2026

    Report

    Report Number
    3011175548-2026-000000
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 19, 2025
    Report Date
    February 18, 2026
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    NIO
    UDI-DI
    00650862853391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 EVENT SITE NAME: (B)(6). D1- RELATED STENT INVOLVED: SERIAL #: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. THIS EVENT OCCURRED ON THE GERMANY MARKET ON A DEVICE THAT IS DISTRIBUTED EXCLUSIVELY OUTSIDE OF THE USA. THEREFORE, NO GUDID INFORMATION EXISTS. UDI INFORMATION PROVIDED IN D4 IS FOR THE ADVANTA STENT (OUS DEVICE). IT IS A SIGNIFICANTLY SIMILAR DEVICE TO ICAST STENT WHICH IS SOLD IN THE USA UNDER PRIMARY DI NUMBER (B)(4), PREMARKET SUBMISSION NUMBER P120003.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6. RELATED MDR: 3011175548-2026-0000007. CUSTOMER REPORTED THAT DURING PLACEMENT OVER 12 FR. SHEATH TWO V12 STENTS PEELED OFF FROM THE CATHETER SHAFT. THIS CREATED DIFFICULT CONDITIONS DURING THE PROCEDURE. BOTH STENTS HAD TO BE REMOVED FROM THE VESSELS. THERE WAS NO HARM OR INJURY REPORTED. UPON RECEIVING THIS COMPLAINT MULTIPLE QUESTIONS WERE ASKED OF THE COMPLAINANT MULTIPLE TIMES WITHOUT ANY ANSWERS. THE MOST PERTINENT QUESTION ASKED WAS ¿DID THE STENTS COME OFF DURING WITHDRAWAL OF THE STENTS BACK INTO THE SHEATH? IF SO, WHY WERE THE STENTS ATTEMPTED TO BE WITHDRAWN BACK INTO THE SHEATH?¿ THE COMPLAINT CONSISTS OF TWO ADVANTA V12 COVERED STENT CATHETERS WITH PRE-MOUNTED STENTS. ONE DEVICE WAS AN ADVANTA V12 6MM X 59MM X 120CM COVERED STENT DELIVERY SYSTEM AND THE OTHER WAS A 9MM X 59MM X 120CM. THE TWO PRODUCTS IN QUESTION WERE NOT RETURNED FOR EVALUATION. THERE WERE NO IMAGES PROVIDED FROM THE CLINICAL PROCEDURE SUCH AS FLUOROSCOPIC IMAGES OF THE CATHETERS TRACKING INTO THE T-BRANCH GRAFT OR THE STENTS BECOMING DISLODGED. THERE WERE ALSO NO IMAGES OF THE DEVICES USED AFTER THE PROCEDURE. AS SUCH THE COMPLAINT CANNOT BE CONFIRMED. CONTEMPORANEOUS SAMPLES FROM INVENTORY WERE NOT REQUESTED AS THE CONDITIONS DURING THE CLINICAL PROCEDURE ARE UNKNOWN AND WOULD NOT BE ABLE TO BE DUPLICATED. A FULL REVIEW OF THE TWO PRODUCT DEVICE HISTORY RECORDS SHOWS THAT THERE WERE NO NON-CONFORMANCES DURING THE PRODUCT BUILDS RELATED TO THE STENT RETENTION OF THE STENTS TO THE BALLOON OF THE CATHETER. ALL STENT RETENTION TEST DATA SHOWS THAT IT MET SPECIFICATIONS. THERE IS NO INDICATION THAT A DESIGN, MANUFACTURING SPECIFICATION, TEST METHOD, MANUFACTURING PROCESS, EQUIPMENT OR RAW MATERIAL WAS THE CAUSE OF THE COMPLAINT. A RECURRING LOT NUMBER QUERY WAS CONDUCTED FOR L/N 522444 AND THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THE PRODUCTION LOT OF FINISHED GOODS. A HISTORICAL REVIEW OF CAPA AND NCRS WAS COMPLETED, WHICH DID NOT IDENTIFY ANY ISSUES DIRECTLY RELATED TO THIS COMPLAINT. A COMPLAINT HISTORY REVIEW DID IDENTIFY SEVERAL COMPLAINTS, AND NONE WERE CONFIRMED TO BE THE FAULT OF THE DEVICE. THE STENTS IN THESE COMPLAINTS WERE EITHER DISLODGED WHILE TRACKING THROUGH THE SHEATH OR NAVIGATING TORTUOUS ANATOMY OR PULLING THE UNDEPLOYED STENT BACK INTO THE INTRODUCER SHEATH. A RISK REVIEW FOUND THAT THE RISK MANAGEMENT DOCUMENTS FOR THIS PRODUCT ADEQUATELY ADDRESS THE REPORTED DEFECT AND THE SEVERITY AND ANTICIPATED OCCURRENCE LEVEL ARE APPROPRIATE. AS THERE IS VERY LIMITED INFORMATION REGARDING THE COMPLAINT THE ROOT CAUSE IS EXTREMELY DIFFICULT TO DETERMINE. AS THE DETAILS DO MENTION THAT THE STENTS HAD TO BE REMOVED FROM THE VESSEL SUGGEST THAT THE STENT HAD EXITED THE DISTAL END OF THE 12FR INTRODUCER SHEATH. BOTH THE PRODUCTS ARE LABELED FOR A 7FR INTRODUCER SHEATH HOWEVER THE DETAILS MENTION THAT THE PRODUCT WAS ADVANCED THROUGH A 12FR INTRODUCER SHEATH. THIS IS A MUCH LARGER INTRODUCER SHEATH THAN THE LABELED 7FR INTRODUCER SHEATH. AS THE SHEATH WAS MUCH LARGER THAN THE RECOMMENDED INTRODUCER SHEATH IT IS POSSIBLE THAT THE 12FR INTRODUCER SHEATH KINKED DURING THE PROCEDURE IF THE ANATOMY WERE TORTUOUS. IF THE STENTS AT ANY POINT DURING THE PROCEDURE WERE ATTEMPTED TO BE WITHDRAWN BACK INTO THE INTRODUCER SHEATH IT IS POSSIBLE THAT THE STENTS WERE PUSHED OFF THE CRIMPED POSITION OF THE BALLOON CATHETER. IF THIS WERE TO OCCUR THE STENTS WOULD HAVE BEEN PUSHED OFF THE BALLOON DISTALLY INTO THE VASCULATURE AS DESCRIBED. THERE SHOULD BE, HOWEVER, A GUIDE WIRE IN PLACE WHERE THE STENTS WOULD STILL BE SITTING AND NOT FREE FLOATING IN THE VESSEL. THE INSTRUCTIONS FOR USE AW011785 REVISION AA ARE VERY CLEAR TO NOT TRY TO PULL AN UNDEPLOYED STENT BACK THROUGH THE INTRODUCER SHEATH. BASED ON THE INFORMATION PROVIDED THERE IS NO EVIDENCE THAT EITHER DEVICE WAS MANUFACTURED IMPROPERLY. THE MOST LIKELY ROOT CAUSE IS IMPOSSIBLE TO DEFINE HOWEVER IT IS LIKELY THAT THE STENTS WERE PUSHED OFF THE BALLOON WHILE PULLING THE STENTS BACK INTO THE SHEATH. THIS CANNOT BE CONFIRMED WITHOUT FLUOROSCOPIC IMAGES FROM THE PROCEDURE.

    Description of Event or Problem · 0

    DURING THE T-BRANCH PROCEDURE, TWO V12 STENTS PEELED OFF FROM THE CATHETER SHAFT WHILE BEING PLACED OVER THE 12 FR SHEATH. THIS RESULTED IN DIFFICULT CONDITIONS DURING THE PROCEDURE SO BOTH STENTS WERE REMOVED FROM THE VESSELS. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259988 ADVANTA V12,COVERED STENTSYS, 9X59X120 STENT, ILIAC NIO ATRIUM MEDICAL CORPORATION 85339 522444 00650862853391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown T-BRANCH ENDOGRAFT, 12 FR SHEATH.