BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA V12 COVERED STENT SYSTEM

    MDR report key: 22800968 · Received August 13, 2025

    Report

    Report Number
    3011175548-2025-000009
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    April 1, 2025
    Report Date
    September 18, 2025
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    NIO
    UDI-DI
    00650862853605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FIELDS: H3, H6 CORRECTED DATA: H11 THIS EVENT OCCURRED ON THE CANADA 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. THE CUSTOMER REPORTED THAT THE ADVANTA V12 BALLOON RUPTURED AND FRACTURED AFTER DEPLOYMENT. THE BALLOON WAS UNABLE TO BE RETRIEVED AND THEREFORE THE PATIENT HAD TO GO TO THE OR FOR ADDITIONAL SURGERY. THE DEVICE IN QUESTION WAS NOT RETURNED AND NO IMAGES OF THE DEVICE WERE PROVIDED, THEREFORE THE COMPLAINT CANNOT BE CONFIRMED. ADDITIONAL INFORMATION PROVIDED STATED THAT THE LESION BEING TREATED WAS CALCIFIED AND THAT NO PRE-DILATION WAS REQUIRED PRIOR TO THE ADVANCEMENT OF THE V12 STENT. BASED ON THE LIMITED AMOUNT OF DETAILS PROVIDED AND LACK OF THE PHYSICAL DEVICE IT IS LIKELY THAT THE BALLOON OF THE CATHETER RUPTURED ON THE CALCIFIC LESION UPON DEPLOYMENT OF THE STENT. THE INSTRUCTION FOR USE (IFU) CONTRAINDICATES THE USE OF THE ¿ADVANTA V12 WITHIN HEAVILY CALCIFIED LESIONS RESISTANT TO PTA¿. IF THERE HAD BEEN A HOLE IN THE BALLOON PRIOR TO USE IT WOULD HAVE LIKELY BEEN NOTICED WHILE PREPPING THE DEVICE FOR USE AS THE INSTRUCTIONS FOR USE REQUIRE THE BALLOON BE HOOKED UP TO A 20CC SYRINGE AND A VACUUM PULLED AS DESCRIBED IN THE IFU. THE CATHETER DELIVERY SYSTEMS ARE 100% PRESSURE TESTED AT THE RATED BUST PRESSURE OF THE DEVICE OF 12ATM AS INDICATED ON THE PRODUCT LABEL. THIS IS CONDUCTED PRIOR TO THE STENT BEING CRIMPED ON TO THE CATHETER. ONCE THE STENT IS CRIMPED ON TO THE CATHETER THERE IS A SECONDARY LEAK CHECK CONDUCTED TO ENSURE THAT THE INTEGRITY OF THE BALLOON AND CATHETER WERE NOT DAMAGED DURING THE CRIMP PROCESS. THE DEVICE HISTORY RECORDS SHOW THAT NO DEVICES FAILED EITHER OF THE LEAK CHECKS CONDUCTED. AS THE BALLOON HAD BEEN SEPARATED FROM THE CATHETER IT IS LIKELY THAT THE BALLOON WAS UNABLE TO BE FULLY DEFLATED PRIOR TO WITHDRAWAL BACK THROUGH THE INTRODUCER SHEATH AS IT WAS NOTED THAT BLOOD HAD ENTERED THE 20CC SYRINGE WHILE ATTEMPTING TO DEFLATE THE BALLOON. IN THIS REGARD IT IS POSSIBLE ONLY A PORTION OF THE BALLOON DEFLATED. IF THIS WERE THE CASE IT IS POSSIBLE THAT EXCESSIVE FORCE MAY HAVE BEEN ATTEMPTED TO PULL THE BALLOON CATHETER BACK THROUGH THE INTRODUCER SHEATH CAUSING THE BALLOON, OR A PORTION OF THE BALLOON TO DETACH FROM THE CATHETER SHAFT 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 516787 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 BALLOON BURST, WHICH WERE ASSOCIATED WITH PROCEDURE COMPLICATIONS THAT RESULTED IN THE RUPTURE OF THE BALLOON OF THE CATHETER. 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 INFORMATION PROVIDED IN THE COMPLAINT, THERE IS NO EVIDENCE TO CONCLUDE THAT THE DEVICE WAS FAULTY OR MANUFACTURED IMPROPERLY. BASED ON THE DETAILS THE BALLOON LIKELY RUPTURED ON THE CALCIFIC LESION. IN THIS REGARD THE ROOT CAUSE IS RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    THIS EVENT OCCURRED ON THE CANADA MARKET ON A DEVICE THAT IS DISTRIBUTED EXCLUSIVELY OUTSIDE OF THE USA. THEREFORE, NO GUDUD 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 K050814. UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER DEPLOYMENT OF ADVANTA V12 STENT, THE BALLOON RUPTURED AND WHILE ATTEMPTING TO RETRIEVE THE RUPTURED BALLOON IT BROKE AND SEPARATED FROM THE CATHETER (FRACTURED). THE OPERATOR WAS UNABLE TO RETRIEVE THE BALLOON, AND THE PATIENT HAD TO GO TO THE OR URGENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557070 ADVANTA V12 COVERED STENT SYSTEM STENT, ILIAC NIO ATRIUM MEDICAL CORPORATION 85360 516787 00650862853605

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention 7FR TERUMO DESTINATION.