BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS ENDOVASCULAR STENT GRAFT

    MDR report key: 6212699 · Received December 29, 2016

    Report

    Report Number
    9681442-2016-00336
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 2, 2016
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    UDI-DI
    04049519008653
    PMA / PMN Number
    P130029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    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. THE EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. THE STENT GRAFT WAS FOUND TO BE LOADED IN THE SYSTEM. THE OUTER SHEATH WAS FOUND TO BE ELONGATED AND FRACTURED INDICATING THAT INCREASED FRICTION MUST HAVE AFFECTED ON THE DELIVERY SYSTEM DURING THE ATTEMPT TO DEPLOY THE STENT GRAFT. THE OUTER SHEATH FRACTURE MADE A COMPLETE STENT GRAFT DEPLOYMENT IMPOSSIBLE. POTENTIAL CONTRIBUTING FACTORS 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 SHEATH FRACTURE. INSUFFICIENT FLUSHING OF THE DEVICE MAY BE ANOTHER CONTRIBUTING FACTOR TO THE REPORTED EVENT. ON THE BASIS OF THE INFORMATION AVAILABLE AND THE EVALUATION OF THE SAMPLE RETURNED, A DEFINITE ROOT CAUSE FOR THE REPORTED FAILURE 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."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT OF A STENOSIS IN A CEPHALIC-AXILLARY ANASTOMOSIS VIA BRACHIOCEPHALIC AVF THE STENT GRAFT FAILED TO DEPLOY AND THE OUTER CATHETER FRACTURED. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00335.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT OF A STENOSIS IN A CEPHALIC-AXILLARY ANASTOMOSIS VIA BRACHIOCEPHALIC ACCESS, THE STENT GRAFT FAILED TO DEPLOY AND THE OUTER CATHETER FRACTURED. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00335.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862241 FLUENCY PLUS ENDOVASCULAR STENT GRAFT ENDOVASCULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANAN3561 04049519008653

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR