BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUENCY PLUS VASCULAR STENT GRAFT

    MDR report key: 9256557 · Received October 30, 2019

    Report

    Report Number
    9681442-2019-00204
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    February 27, 2019
    Report Date
    October 30, 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

    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: LUO, X., ZHAO, M., WANG, X., JIANG, M., YU, J., LI, X., & YANG, L. (2019). LONG-TERM PATENCY AND CLINICAL OUTCOME OF THE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT USING THE EXPANDED POLYTETRAFLUOROETHYLENE STENT-GRAFT. PLOS ONE, 14(2). DOI: 10.1371/JOURNAL.PONE.0212658. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF PLOS ONE TITLED " LONG-TERM PATENCY AND CLINICAL OUTCOME OF THE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT USING THE EXPANDED POLYTETRAFLUOROETHYLENE STENT-GRAFT " THAT IN A RETROSPECTIVE STUDY OF 495 PATIENTS WHO UNDERWENT TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) WITH THE FLUENCY STENT-GRAFTS BETWEEN DECEMBER 2011 AND JUNE 2015, TIPS-RELATED COMPLICATIONS OCCURRED IN 67 PATIENTS DURING THE INDEX HOSPITAL STAY. THE PATIENTS RESPONDED WELL TO THE CONSERVATIVE TREATMENT FOR POST-TIPS INFECTION (60), PULMONARY EMBOLIZATION (1), INTRA-ABDOMINAL BLEEDING (4) AND BILE DUCT INJURY WITH BILIARY HEMORRHAGE (1), STENT REVISION WAS REQUIRED FOR THE PATIENTS WITH SHUNT OCCLUSION (18) AND STENOSIS (19), HOWEVER, THE PATENT STATUS WAS NOT PROVIDED FOR HEPATIC ENCEPHALOPATHY (151) AND VARICEAL REBLEEDING (43).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050521 FLUENCY PLUS VASCULAR STENT GRAFT VASCULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R