BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA V12,COVERED STENTSYS,10X59X120

    MDR report key: 23766391 · Received December 10, 2025

    Report

    Report Number
    3011175548-2025-000012
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 18, 2025
    Report Date
    January 30, 2026
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    NIO
    UDI-DI
    00650862853650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SECTION: D6A, H6. RELATED MDR: 3011175548-2025-0000128. THE CUSTOMER REPORTED THAT DURING THE PLACEMENT OF TWO V12 STENTS (10 × 59 × 120 MM) IN A 70-YEAR-OLD PATIENT WITH A HISTORY OF COLON CANCER AND A THORACIC AND ABDOMINAL AORTIC ENDOGRAFT FOR ANEURYSM, A KISSING-STENT PROCEDURE WAS PERFORMED AT THE AORTO-ILIAC BIFURCATION. THIS APPROACH WAS CHOSEN BECAUSE THE PREVIOUSLY IMPLANTED ENDOGRAFT PRESENTED A CERTAIN DEGREE OF NARROWING AT THAT LEVEL. BOTH STENTS WERE DEPLOYED WITHOUT DIFFICULTY. HOWEVER, DURING THE WITHDRAWAL OF THE BALLOON FROM THE FIRST STENT THE BALLOON BECAME STUCK IN THE INTRODUCER. THE INTRODUCER HAD TO BE REMOVED TOGETHER WITH THE BALLOON, WHILE THE GUIDEWIRE REMAINED IN PLACE. FOR THE SECOND BALLOON, REMOVAL WAS POSSIBLE BUT DIFFICULT. THE TWO 10MM X 59MM DEVICES WERE RETURNED AND EVALUATED. BOTH DEVICES WERE EXTREMELY CLEAN AND THE VOID OF ANY BLOOD STAINING. THE FIRST DEVICE WAS MISSING THE ENTIRE BALLOON. THE CATHETER SHAFT HAS BEEN ELONGATED AND APPEARS THAT JUST BEFORE THE PROXIMAL BALLOON WELD THE SHAFT NECKED DOWN TO A SMALLER DIAMETER AND THE BALLOON SEPARATED FROM THE CATHETER SHAFT AT THIS LOCATION. THE BALLOON THAT HAD BEEN SEPARATED WAS NOT RETURNED. THE SECOND DEVICE WAS FULLY INTACT AND HAD A VERY SLIGHT ELONGATION AT THE PROXIMAL WELD. TO DETERMINE IF THE BALLOON OR CATHETER SYSTEM HAD A LEAK THE BALLOON WAS INFLATED WITH WATER AND PRESSURIZED TO 12 ATM AS THIS IS THE RATED BURST PRESSURE OF THE CATHETER AS INDICATED ON THE PRODUCT LABEL. THERE WERE NO LEAKS IDENTIFIED. THE BALLOON WAS THEN DEFLATED WITHOUT ISSUE. ALSO PROVIDED WAS A NEW TERUMO RADIFOCUS 7FR INTRODUCER SHEATH REFERENCE NUMBER RS+R7ON1OMQ. THIS SHEATH IS PART OF A KIT AND HAS A SUPPLIED SHORT GUIDE WIRE THAT IS .038¿IN. THE ADVANTA V12 REQUIRES THE USE OF A .035¿IN GUIDE WIRE AS INDICATED ON THE PRODUCT LABEL. TO EVALUATE THE ONE FULLY INTACT DEVICE FURTHER A .035 EMERALD GREEN GUIDE WIRE WAS PLACED ENTIRELY THROUGH THE CATHETER AND THE BALLOON FOLDED BY HAND AND ADVANCED THROUGH THE PROVIDED INTRODUCER SHEATH. THE BALLOON WAS AGAIN INFLATED TO 12 ATM AND THE BALLOON DEFLATED. THE BALLOON FULLY DEFLATED WITH WATER WITHIN 27 SECONDS. THIS IS IMPORTANT AS THE DETAILS PROVIDED STATE ¿WAITING FOR COMPLETE DEFLATION (TIMED AT 30 SECONDS)¿. WHEN USING CONTRAST MEDIA WITH A 50/50 DILUTION OF CONTRAST AND SALINE DEFLATION TIME WOULD BE GENERALLY 2X LONGER THAN JUST PLAIN WATER SO THE EXPECTATION WOULD BE THAT DEFLATION TIME WITH THE CONTRAST MEDIUM WOULD BE CLOSER TO 60 SECONDS OR MORE DEPENDING ON THE DILUTION. THE BALLOON ONCE DEFLATED WAS WITHDRAWN BACK THROUGH THE PROVIDED 7FR INTRODUCER SHEATH WITHOUT ISSUE EVEN WITH THE PROXIMAL BALLOON WELD THAT HAD ALREADY BEEN STRETCHED DURING THE PROCEDURE. A REVIEW OF THE INFLATION SKIVES UNDER THE BALLOON OF THE ONE FULLY INTACT DEVICE WERE INSPECTED AND BOTH WERE PRESENT AND PATENT AS WATER WAS SEEN ENTERING THE BALLOON FROM BOTH THE PROXIMAL AND DISTAL SKIVE HOLES UNDER THE BALLOON. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THAT THERE WERE NO NON-CONFORMANCES NOTED AND THE PRODUCT MET ALL QUALITY AND PERFORMANCE REQUIREMENTS. 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 522063 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 RELATED COMPLAINTS INVOLVING DIFFICULT OR UNABLE TO WITHDRAW CATHETER, WHICH WERE ASSOCIATED WITH THE DELIVERY SYSTEM BEING WITHDRAWN BEFORE THE BALLOON WAS COMPLETELY DEFLATED OR THE BALLOON HAD A HOLE IN IT. 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. BASED ON THE DETAILS OF THE PROCEDURE AND EVALUATION OF THE RETURNED DEVICES THE ROOT CAUSE IS LIKELY RELATED TO USER ERROR FOR NOT WAITING FOR THE BALLOON TO FULLY DEFLATE PRIOR TO WITHDRAWAL. THE COMPLAINT HAS BEEN CONFIRMED BASED ON THE RETURNED PRODUCT INVESTIGATION HOWEVER THERE IS NO EVIDENCE TO CONCLUDE THAT THE DEVICES WERE DEFECTIVE WHEN MANUFACTURED.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1. E1 EVENT SITE ADDRESS: (B)(6). D1: SERIAL NUMBER FOR THE SECOND STENT INVOLVED- (B)(6) AND UDI- (B)(4). RELATED COMPLAINT FOR OTHER STENT INVOLVED- (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    THE REPORT RECEIVED STATED THAT DURING A KISSING STENT PROCEDURE AT THE AORTO-ILIAC BIFURCATION, TWO V12 STENTS WERE SUCCESSFULLY DEPLOYED. DURING THE WITHDRAWAL OF THE BALLOON FROM THE FIRST STENT, IT WAS VERIFIED THAT THE BALLOON WAS COMPLETELY DEFLATED, AND THE DEFLATION WAS CONFIRMED UNDER FLUOROSCOPY, AND THE TOTAL AMOUNT OF CONTRAST RETRIEVED; HOWEVER, THE BALLOON BECAME STUCK IN THE INTRODUCER. THE INTRODUCER HAD TO BE REMOVED TOGETHER WITH THE BALLOON, WHILE THE GUIDEWIRE REMAINED IN PLACE. FOR THE SECOND BALLOON, WITHDRAWAL OF THE BALLOON WAS COMPLETED BUT WAS DIFFICULT. THERE WERE TWO S/NS REPORTED, BUT IT IS UNCLEAR WHICH ONE WAS INVOLVED IN EACH SPECIFIC INCIDENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT, AND THE STENTS REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166759 ADVANTA V12,COVERED STENTSYS,10X59X120 STENT, ILIAC NIO ATRIUM MEDICAL CORPORATION 85365 522063 00650862853650

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male TERUMO 7 FR RADIFOCUS