BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUENCY PLUS ENDOVASCULAR STENT GRAFT

    MDR report key: 9251303 · Received October 29, 2019

    Report

    Report Number
    9681442-2019-00203
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    September 30, 2019
    Report Date
    December 20, 2019
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    UDI-DI
    04049519008493
    PMA / PMN Number
    P130029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AFTER FURTHER REVIEW OF THE DETAILS PROVIDED BY THE COMPLAINANT, IT WAS IDENTIFIED THAT THE FDA RN NUMBER AND MANUFACTURER (D3) WAS INCORRECT; THE CORRECT FDA RN NUMBER IS (B)(4) AND THE CORRECT MANUFACTURER (D3) IS BARD PERIPHERAL VASCULAR, INC. THIS NUMBER WILL NOT BE CHANGED ON THE EMDR SO THAT THIS REPORT WILL REMAIN CONNECTED AND IDENTIFY THAT THE EVENT WAS REPORTED TO THE FDA IN A TIMELY MANNER. MANUFACTURING REVIEW: A MANUFACTURING RECORD REVIEW WAS NOT PERFORMED, AS THE INFORMATION AVAILABLE DOES NOT REASONABLY SUGGEST A MANUFACTURING PROCESS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. INVESTIGATION SUMMARY: THE STENT GRAFT DELIVERY SYSTEM WAS RETURNED FOR EVALUATION. A BREAK AS REPORTED BY THE CUSTOMER OR ANOTHER DEVICE DEFICIENCY COULD NOT BE DETERMINED. EVEN THOUGH THE CONDITION OF THE SAMPLE INDICATED THAT THE Y-INJECTION-ADAPTER MAY BE PUSHED IN DISTAL DIRECTION INSTEAD OF DIRECTION TOWARDS THE HANDGRIP, THE EVENT EXPERIENCED BY THE CUSTOMER COULD NOT BE REPRODUCED. BASED ON THE INFORMATION AVAILABLE THE INVESTIGATION IS CLOSED WITH INCONCLUSIVE RESULT. A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. LABELING REVIEW: IN REVIEWING THE RELEVANT LABELING FOR THIS PRODUCT IT WAS FOUND THAT THE INSTRUCTIONS FOR USE (IFU) SUFFICIENTLY DESCRIBES CORRECT DEPLOYMENT TECHNIQUE. THE IFU STATES: "TO DEPLOY THE IMPLANT, PIN THE HANDGRIP ON A STABLE SURFACE WITH YOUR BACK HAND AND SLOWLY PULL THE Y-INJECTION-ADAPTER WITH YOUR FRONT HAND TOWARDS THE HANDGRIP. THIS ACTION RETRACTS THE OUTER SHEATH AND EXPOSES A CORRESPONDING PORTION OF THE STENT GRAFT. THE BACK HAND SHOULD STAY FIXED IN POSITION WITH SLIGHT ADJUSTMENTS AS NECESSARY TO ALLOW FOR PROPER DEPLOYMENT (...)." CORRECT DEPLOYMENT TECHNIQUE IS ALSO DEMONSTRATED BY AN ILLUSTRATION. POTENTIAL RISK OF INCREASED DEPLOYMENT FORCES ARE ADDRESSED: "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 ANATOMY OF THE PLACEMENT SITE THE IFU STATES: "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."; "PRIOR TO LOADING THE ENDOVASCULAR SYSTEM OVER A GUIDE WIRE, BOTH PORTS MUST BE FLUSHED WITH STERILE SALINE (¿) FLUSHING THESE LUMENS WILL ALSO FACILITATE STENT GRAFT DEPLOYMENT." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TREATMENT OF A 90% STENOSIS VIA UPPER RIGHT ARM A/V GRAFT, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY AND THE DELIVERY SYSTEM ALLEGEDLY BROKE (DETAILS UNKNOWN). THEREFORE, THE DEVICE WAS REMOVED WITHOUT ISSUE. REPORTEDLY, THE PATIENT IS BEING RETURNED FOR A SECOND INTERVENTION, AS THERE WAS NO ADDITIONAL DEVICE AVAILABLE TO COMPLETE THE PROCEDURE. THE PATIENT IS CURRENTLY STABLE.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT OF A 90% STENOSIS VIA UPPER RIGHT ARM A/V GRAFT, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY AND THE DELIVERY SYSTEM ALLEGEDLY BROKE (DETAILS UNKNOWN). THEREFORE, THE DEVICE WAS REMOVED WITHOUT ISSUE. REPORTEDLY, THE PATIENT IS BEING RETURNED FOR A SECOND INTERVENTION, AS THERE WAS NO ADDITIONAL DEVICE AVAILABLE TO COMPLETE THE PROCEDURE. THE PATIENT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046887 FLUENCY PLUS ENDOVASCULAR STENT GRAFT ENDOVASCULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FEM08060 ANDS0329 04049519008493

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention