BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLUENCY PLUS VASCULAR STENT GRAFT

    MDR report key: 9335595 · Received November 18, 2019

    Report

    Report Number
    9681442-2019-00219
    Event Type
    Death
    Date Received
    November 18, 2019
    Date of Event
    March 29, 2018
    Report Date
    November 18, 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 IN 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: LUO, J., LI, M., ZHANG, Y., WANG, H., HUANG, M., LI, Z., ¿ JIANG, Z. (2018). PERCUTANEOUS TRANSHEPATIC INTRAHEPATIC PORTOSYSTEMIC SHUNT FOR VARICEAL BLEEDING WITH CHRONIC PORTAL VEIN OCCLUSION AFTER SPLENECTOMY. EUROPEAN RADIOLOGY, 28(9), 3661¿3668. DOI: 10.1007/S00330-018-5360-Z.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE FROM THE JOURNAL OF EUROPEAN RADIOLOGY TITLED " PERCUTANEOUS TRANSHEPATIC INTRAHEPATIC PORTOSYSTEMIC SHUNT FOR VARICEAL BLEEDING WITH CHRONIC PORTAL VEIN OCCLUSION AFTER SPLENECTOMY " THAT IN A RETROSPECTIVE STUDY OF 24 PATIENTS WHO RECEIVED PERCUTANEOUS TRANSHEPATIC INTRAHEPATIC PORTOSYSTEMIC SHUNT (PTIPS), ONE PATIENT (NO. 3) DIED AS A RESULT OF SHUNT DYSFUNCTION AND REBLEEDING 22 MONTHS AFTER PTIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129295 FLUENCY PLUS VASCULAR STENT GRAFT VASCULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HEPARIN POSTOP 3-5 DAYS| ORAL WARFARIN 6 MONTHS - 1 YEAR