BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUENCY PLUS VASCULAR STENT GRAFT

    MDR report key: 9344739 · Received November 19, 2019

    Report

    Report Number
    9681442-2019-00229
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    September 24, 2017
    Report Date
    November 19, 2019
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    PMA / PMN Number
    P130029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER IDENTIFIED HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT PRODUCTS THAT ARE CLEARED IN THE US. THE 510 K NUMBER AND PRO CODE FOR THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT PRODUCTS ARE IDENTIFIED. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. (B)(4). JOURNAL ARTICLE CITATION: WAN, Y.-M., LI, Y.-H., XU, Y., WU, H.-M., LI, Y.-C., WU, X.-N., & YANG, J.-H. (2018). PREDICTORS OF SHUNT DYSFUNCTION AND OVERALL SURVIVAL IN PATIENTS WITH VARICEAL BLEEDING TREATED WITH TRANSJUGULAR PORTOSYSTEMIC SHUNT CREATION USING THE FLUENCY STENT GRAFT. ACADEMIC RADIOLOGY, 25(7), 925¿934. DOI: 10.1016/J.ACRA.2017.11.020.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE FROM THE JOURNAL OF ACADEMIC RADIOLOGY TITLED " PREDICTORS OF SHUNT DYSFUNCTION AND OVERALL SURVIVAL IN PATIENTS WITH VARICEAL BLEEDING TREATED WITH TRANSJUGULAR PORTOSYSTEMIC SHUNT CREATION USING THE FLUENCY STENT GRAFT " THAT PERIPROCEDURAL COMPLICATIONS WERE OBSERVED IN 53 PATIENTS: NAUSEA AND VOMITING (25), BLEEDING FROM THE PUNCTURE SITE AT THE NECK (16), TRANSIENT RESPIRATORY DISTRESS AND TACHYCARDIA (7), AND HEPATIC CAPSULAR PUNCTURE LEADING TO INTRAABDOMINAL BLEEDING (5), WHICH WERE SUCCESSFULLY MANAGED BY CONSERVATIVE TREATMENT. STENT DYSFUNCTION WAS IDENTIFIED IN 63 PATIENTS; 30 HAD SHUNT STENOSIS AND 33 HAD SHUNT OCCLUSION. 62 UNDERWENT TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) REVISIONS, INCLUDING BALLOON ANGIOPLASTY, THROMBECTOMY, THROMBOASPIRATION, AND THROMBOLYSIS COMBINED AND INSERTION OF ONE OR TWO NEW STENT GRAFTS. THE STATUS OF THE PATIENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137082 FLUENCY PLUS VASCULAR STENT GRAFT VASULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R