BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS ENDOVASCULAR STENT GRAFT

    MDR report key: 6137619 · Received December 1, 2016

    Report

    Report Number
    9681442-2016-00315
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Report Date
    November 7, 2016
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    UDI-DI
    04049519008363
    PMA / PMN Number
    P130029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 SAMPLE EVALUATION, THE REPORTED EVENT COULD BE CONFIRMED. THE STENT GRAFT WAS FOUND TO BE PARTIALLY DEPLOYED. POTENTIAL FACTORS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN CONSIDERED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THIS TYPE OF EVENT MAY BE ASSOCIATED WITH A DIFFICULT VESSEL ANATOMY LEADING TO INCREASED FRICTION AND SUBSEQUENT PARTIAL STENT GRAFT DEPLOYMENT. INSUFFICIENT FLUSHING OF THE DEVICE MAY BE ANOTHER CONTRIBUTING FACTOR TO THE REPORTED EVENT. IN THIS CASE, NO INFORMATION REGARDING THE PROCEDURE AND THE VESSEL ANATOMY WAS PROVIDED. 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 THAT THE DEVICE MUST BE FLUSHED WITH STERILE SALINE. ALSO THE IFU STATES: "THE SAFETY AND EFFECTIVENESS OF THE DEVICE WHEN PLACED ACROSS A TIGHT BEND (...) 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." AND "DO NOT KINK THE DELIVERY CATHETER OR USE EXCESSIVE FORCE DURING DELIVERY TO THE TARGET LESION." FURTHERMORE, 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." UPDATED 'EVAL CODE & DESC - CONCLUSION1' DUE TO COMPLETION OF EVALUATION.

    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 PATIENT OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED ANY FURTHER AFTER BEING RELEASED A QUARTER OF THE WAY. REPORTEDLY, THERE WERE NO RETRACTION ISSUES AND THE PROCEDURE WAS COMPLETED BY USING A PTA BALLOON TO TAMPONADE. 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 COULD NOT BE DEPLOYED ANY FURTHER AFTER BEING RELEASED A QUARTER OF THE WAY. REPORTEDLY, THERE WERE NO RETRACTION ISSUES AND THE PROCEDURE WAS COMPLETED BY USING A PTA BALLOON TO TAMPONADE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787993 FLUENCY PLUS ENDOVASCULAR STENT GRAFT ENDOVASCULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANYI0772 04049519008363

    Patients

    Seq Age Sex Outcome Treatment
    1