BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    MDR report key: 4852599 · Received June 16, 2015

    Report

    Report Number
    9681442-2015-00068
    Event Type
    Injury
    Date Received
    June 16, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    JCT
    PMA / PMN Number
    K050832
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET THE SPECIFICATION PRIOR TO SHIPMENT. THE REVIEW SHOWED THAT NO REMARKABLE INCIDENTS OCCURRED DURING THE MANUFACTURING PROCESS. NO RELEVANT MANUFACTURING PROCESS CHANGES WERE IMPLEMENTED, THAT COULD HAVE LED TO THE EVENT REPORTED. BASED ON THE SAMPLE EVALUATION THE REPORTED FAILURE COULD BE CONFIRMED. THE STENT GRAFT WAS FOUND PARTIALLY RELEASED AND THE OUTER SHEATH WAS FOUND ELONGATED, WHICH INDICATES THAT INCREASED RELEASED FORCE WAS PRESENT DURING ATTEMPT OF DEPLOYMENT. FURTHERMORE, THE OUTER SHEATH WAS FOUND PERFORATED BY A STENT GRAFT STRUT, WHICH MADE A STENT GRAFT DEPLOYMENT IMPOSSIBLE. NO INDICATION WAS FOUND FOR MANUFACTURING RELATED ISSUES. POTENTIAL FACTORS WHICH MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE HAVE BEEN CONSIDERED. THEREFORE PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THE STENT GRAFT COULD NOT BE DEPLOYED DUE TO STENT GRAFT STRUT PERFORATING THE DISTAL OUTER SHEATH OF THE DELIVERY SYSTEM. THIS MAY HAVE BEEN ASSOCIATED WITH DIFFICULT ANATOMIC CONDITIONS OR CHALLENGING PLACEMENT SITE, WHICH LED TO INCREASED FRICTION AND SUBSEQUENT TO DAMAGE OF THE OUTER SHEATH. BASED ON THE IMAGES PROVIDED THE STENT GRAFT SHOULD BE PLACED IN A BEND AREA AND THERE WERE REPORTED DIFFICULTIES DURING ADVANCING THE DELIVERY SYSTEM TO THE TARGET LESION. NOT USING AN INTRODUCER SHEATH OR THE USE OF AN INAPPROPRIATE GUIDE WIRE MAY BE CONTRIBUTING FACTORS FOR AN ALLEGED DAMAGE OF THE TIP OF THE DELIVERY SYSTEM AND A SUBSEQUENT PERFORATION. IN THIS CASE, NO INTRODUCER SHEATH WAS USED. BASED ON THE INFORMATION AVAILABLE AND THE EVALUATION OF THE SAMPLE RETURNED, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE IFU STATES: "IF UNUSUAL RESISTANCE OR HIGH DEPLOYMENT FORCE IS ENCOUNTERED DURING STENT GRAFT DEPLOYMENT, ABORT THE PROCEDURE, REMOVE THE DELIVERY SYSTEM AND USE AN ALTERNATIVE DEVICE." REGARDING THE ANATOMY OF THE PLACEMENT SITE THE IFU STATES: "PRIOR TO STENT GRAFT DEPLOYMENT, ENSURE THAT THE PROXIMAL (...) STENT GRAFT END IS POSITIONED IN A STRAIGHT SECTION OF THE LUMEN TO REDUCE THE RISK OF HIGHER DEPLOYMENT FORCES." ADDITIONALLY, REGARDING USE OF ACCESSORIES THE IFU STATES: "THE USE OF AN APPROPRIATELY SIZED INTRODUCER SHEATH IS RECOMMENDED." FURTHERMORE, THE INDICATION OF THE STENT GRAFT PLACEMENT WAS THE TREATMENT OF A PSEUDOANEURYSM IN THE UPPER LEG. BASED ON THE IFUS APPLICABLE FOR THIS PRODUCT THE DEVICE IS INDICATED FOR USE IN THE TREATMENT OF TRACHEOBRONCHIAL STRICTURES PRODUCED BY MALIGNANT NEOPLASMS OR FOR USE IN THE TREATMENT OF IN-STENT RESTENOSIS IN THE VENOUS OUTFLOW OF HEMODIALYSIS PATIENTS DIALYZING BY EITHER AN ARTERIOVENOUS (AV) FISTULA OR AV GRAFT. THE SAFETY AND EFFECTIVENESS OF THE DEVICE WHEN PLACED ACROSS AN ANEURYSM OR A PSEUDOANEURYSM HAS NOT BEEN EVALUATED. THE REPORTED APPLICATION REPRESENTS AN OFF-LABEL USE OF THE DEVICE. AGE AT TIME OF EVENT: > 50 YEARS; THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT WAS UNABLE TO PROVIDE FURTHER PATIENT DETAILS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHEATHLESS STENTING PROCEDURE OF AN UPPER LEG GRAFT PSEUDOANEURYSM, THE STENT GRAFT COULD NOT BE DEPLOYED. THE DEVICE WAS RETRACTED WITHOUT DIFFICULTY AND TWO ADDITIONAL STENT GRAFTS WERE IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392582 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT JCT ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANW12625

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention