BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUENCY PLUS VASCULAR STENT GRAFT

    MDR report key: 9276006 · Received November 4, 2019

    Report

    Report Number
    9681442-2019-00207
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    May 29, 2019
    Report Date
    November 4, 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. JOURNAL ARTICLE CITATION: LV, Y., YANG, Z., HE, C., LI, K., WANG, Z., NIU, J., ¿ HAN, G. (2019). PS-024-EARLY TIPS WITH COVERED STENT VERSUS STANDARD TREATMENT FOR ACUTE VARICEAL BLEEDING AMONG PATIENTS WITH ADVANCED CIRRHOSIS: A RANDOMISED CONTROLLED TRIAL. JOURNAL OF HEPATOLOGY, 70(1). DOI: 10.1016/S0618-8278(19)30030-1.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE FROM THE JOURNAL OF THE LANCET GASTROENTEROLOGY & HEPATOLOGY TITLED " EARLY TIPS WITH COVERED STENTS VERSUS STANDARD TREATMENT FOR ACUTE VARICEAL BLEEDING IN PATIENTS WITH ADVANCED CIRRHOSIS: A RANDOMISED CONTROLLED TRIAL " THAT IN A RANDOMISED CONTROLLED TRIAL OF 132 PATIENTS END POINTS WERE COMPARED BETWEEN EARLY TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNTS (TIPS GROUP) AND CONTROL GROUP (STANDARD TREATMENT GROUP). SIX PATIENTS UNDERWENT TIPS REVISION DUE TO REBLEEDING AND REMAINED FREE FROM REBLEEDING THEREAFTER; TWO PATIENTS RECEIVED MEDICAL AND ENDOSCOPIC TREATMENT FOR THE MANAGEMENT OF REBLEEDING AND REQUIRED LATER SHUNT REVISION FOR STENT STENOSIS ASSOCIATED WITH REBLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069444 FLUENCY PLUS VASCULAR STENT GRAFT VASULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention