BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS ENDOVASCULAR STENT GRAFT

    MDR report key: 6135267 · Received November 30, 2016

    Report

    Report Number
    9681442-2016-00313
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Report Date
    November 4, 2016
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    UDI-DI
    04049519008493
    PMA / PMN Number
    P130029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THERE IS NO INDICATION FOR A MANUFACTURING-RELATED FAILURE. ON THE BASIS OF THE EVALUATION OF THE RETURNED DEVICE, THE REPORTED DEPLOYMENT FAILURE COULD BE CONFIRMED. THE STENT GRAFT WAS FOUND TO BE PARTIALLY RELEASED AND THE OUTER SHEATH WAS FOUND TO BE PERFORATED BY A STENT GRAFT STRUT MAKING SUCCESSFUL STENT GRAFT DEPLOYMENT IMPOSSIBLE. POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED EVENT HAVE BEEN CONSIDERED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THE EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE STENT GRAFT COULD NOT BE FULLY DEPLOYED DUE TO A STENT STRUT PERFORATING THE DISTAL OUTER SHEATH OF THE DELIVERY SYSTEM WHICH MAY BE ASSOCIATED WITH A DIFFICULT VESSEL ANATOMY OR CHALLENGING PLACEMENT SITE LEADING TO INCREASED FRICTION AND SUBSEQUENT DEPLOYMENT DIFFICULTIES. IN THIS CASE, NO INFORMATION ABOUT THE VESSEL ANATOMY WAS PROVIDED. NOT USING AN INTRODUCER SHEATH OR THE USE OF AN INAPPROPRIATELY SIZED GUIDE WIRE ALSO MAY CONTRIBUTE TO TIP DAMAGE AND SUBSEQUENT PERFORATION. INSUFFICIENT FLUSHING OF THE DEVICE MAY BE ANOTHER CONTRIBUTING FACTOR TO INCREASED FRICTION AND SUBSEQUENT DEVICE DAMAGE. ON THE BASIS OF THE INFORMATION AVAILABLE AND THE EVALUATION OF THE SAMPLE, 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 OF THE SAME SIZE." AND "THE SAFETY AND EFFECTIVENESS OF THE DEVICE WHEN PLACED ACROSS A TIGHT BEND INCLUDING THE TERMINAL CEPHALIC ARCH OR ACROSS THE ELBOW JOINT HAS NOT BEEN EVALUATED. PRIOR TO STENT GRAFT DEPLOYMENT, ENSURE THAT THE PROXIMAL (INFLOW) STENT GRAFT END IS POSITIONED IN A STRAIGHT SECTION OF THE LUMEN TO REDUCE THE RISK OF HIGHER DEPLOYMENT FORCES AND POSSIBLE ENDOVASCULAR SYSTEM FAILURE." THE IFU INDICATES THAT AN INTRODUCER SHEATH WITH APPROPRIATE INNER DIAMETER AND A 0.035" (0.89 MM) GUIDE WIRE ARE REQUIRED FOR THE PROCEDURE. ALSO THE IFU INDICATES THAT THE DEVICE MUST BE FLUSHED WITH STERILE SALINE. FURTHERMORE, THE IFU STATES: "DO NOT KINK THE DELIVERY CATHETER OR USE EXCESSIVE FORCE DURING DELIVERY TO THE TARGET LESION."

    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 ANY FURTHER PROCEDURAL DETAILS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE ENDOVASCULAR STENT GRAFT WOULD NOT DISENGAGE FROM THE DELIVERY SYSTEM CATHETER DURING THE ATTEMPT TO DEPLOY THE STENT GRAFT. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE ENDOVASCULAR STENT GRAFT WOULD NOT DISENGAGE FROM THE DELIVERY SYSTEM CATHETER DURING THE ATTEMPT TO DEPLOY THE STENT GRAFT. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786996 FLUENCY PLUS ENDOVASCULAR STENT GRAFT ENDOVASCULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANAU2962 04049519008493

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR