BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS VASCULAR STENT GRAFT

    MDR report key: 9316932 · Received November 13, 2019

    Report

    Report Number
    9681442-2019-00214
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Report Date
    November 13, 2019
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    PMA / PMN Number
    P130029
    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)(6). JOURNAL ARTICLE CITATION: ZUO, L., CHEN, H., WANG, Q., HE, C., YIN, Z., TIE, J., ¿ HAN, G. (2017). EARLY RECURRENT OVERT HEPATIC ENCEPHALOPATHY IS ASSOCIATED WITH POOR SURVIVAL IN PATIENTS WITH CIRRHOSIS AFTER TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT. JOURNAL OF HEPATOLOGY, 66(1). DOI: 10.1016/S0168-8278(17)31087-5.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE FROM THE JOURNAL OF VASCULAR INTERVENTIONAL RADIOLOGY TITLED " EARLY-RECURRENT OVERT HEPATIC ENCEPHALOPATHY IS ASSOCIATED WITH REDUCED SURVIVAL IN CIRRHOTIC PATIENTS AFTER TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT CREATION " THAT DURING FOLLOW-UP, 115 PATIENTS EXPERIENCED OVERT HEPATIC ENCEPHALOPATHY (OHE). PATIENTS WITH SEVERE OHE WERE ADMITTED TO THE INTENSIVE CARE UNIT AND ADMINISTERED EMPIRICAL HE TREATMENT WITH LACTULOSE AND LOW-PROTEIN DIET. REFRACTORY OHE REQUIRED ENDOVASCULAR TREATMENT; SEVEN PATIENTS REQUIRED SHUNT REDUCTION, ONE PATIENT REQUIRED SHUNT OCCLUSION AND FOUR PATIENTS REQUIRED EMBOLIZATION OF THE COLLATERAL VEIN, HOWEVER, ONE PATIENT DID NOT RESPOND TO EMBOLIZATION OF COLLATERAL VEIN UNDERWENT SHUNT OCCLUSION WITH IMPROVED OF OHE. OHE IMPROVED IN ALL TWELVE PATIENTS, WHO REQUIRED AN ADDITIONAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108925 FLUENCY PLUS VASCULAR STENT GRAFT VASCULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R