BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS VASCULAR STENT GRAFT

    MDR report key: 8805580 · Received July 18, 2019

    Report

    Report Number
    9681442-2019-00116
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Report Date
    October 23, 2019
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    UDI-DI
    00801741145803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. BASED ON THE INVESTIGATION OF THE RETURNED CATHETER SAMPLE IT COULD BE CONFIRMED THAT THE USER COULD ONLY PARTIALLY DEPLOY THE STENT GRAFT. THE DEPLOYMENT MECHANISM WAS FOUND IN USED CONDITION, THE STENT GRAFT WAS FOUND PARTIALLY DEPLOYED, AND DURING EVALUATION TESTING A FURTHER DEPLOYMENT WAS IMPOSSIBLE. THE OUTER FORCE TRANSMITTING CATHETER AS FOUND ELONGATED WHICH INDICATED THAT EXCESSIVE RELEASE FORCE MUST HAVE BEEN PRESENT DURING DEPLOYMENT ATTEMPT. AN INDICATION FOR A PROCESS RELATED ISSUE COULD NOT BE FOUND. BASED ON THE INFORMATION AVAILABLE, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE REPORTED APPLICATION REPRESENTS AN OFF LABEL USE OF THE DEVICE. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FVM12100 FLUENCY STENT GRAFT WAS ALLEGEDLY DIFFICULT TO REMOVE AND ALLEGEDLY EXPERIENCED A MISFIRE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED DIFFICULT REMOVAL AND MISFIRE INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS A 79 YEAR-OLD MALE WEIGHING 85 KG.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. BASED ON THE INVESTIGATION OF THE RETURNED CATHETER SAMPLE IT COULD BE CONFIRMED THAT THE USER COULD ONLY PARTIALLY DEPLOY THE STENT GRAFT. THE DEPLOYMENT MECHANISM WAS FOUND IN USED CONDITION, THE STENT GRAFT WAS FOUND PARTIALLY DEPLOYED, AND DURING EVALUATION TESTING A FURTHER DEPLOYMENT WAS IMPOSSIBLE. THE OUTER FORCE TRANSMITTING CATHETER AS FOUND ELONGATED WHICH INDICATED THAT EXCESSIVE RELEASE FORCE MUST HAVE BEEN PRESENT DURING DEPLOYMENT ATTEMPT. AN INDICATION FOR A PROCESS RELATED ISSUE COULD NOT BE FOUND. POTENTIAL FACTORS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE HAVE BEEN CONSIDERED. BASED ON THE SAMPLE RETURNED NO INDICATION FOR A MANUFACTURING RELATED ISSUE COULD BE IDENTIFIED, HOWEVER, A MANUFACTURING RELATED CAUSE WAS CONSIDERED. BASED ON THE INFORMATION AVAILABLE, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FVM12100 FLUENCY STENT GRAFT WAS ALLEGEDLY DIFFICULT TO REMOVE AND ALLEGEDLY EXPERIENCED A MISFIRE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED DIFFICULT REMOVAL AND MISFIRE INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596269 FLUENCY PLUS VASCULAR STENT GRAFT VASCULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANCN2531 00801741145803

    Patients

    Seq Age Sex Outcome Treatment
    1