BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK E-LUMINEXX BILIARY STENT

    MDR report key: 9321865 · Received November 14, 2019

    Report

    Report Number
    9681442-2019-00216
    Event Type
    Injury
    Date Received
    November 14, 2019
    Date of Event
    November 9, 2018
    Report Date
    November 14, 2019
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    FGE
    PMA / PMN Number
    K063532
    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: ZHANG, J.-X., WANG, B., LIU, S., ZU, Q.-Q., & SHI, H.-B. (2018). PREDICTORS OF RECURRENT BILIARY OBSTRUCTION FOLLOWING PERCUTANEOUS UNCOVERED METAL STENT INSERTION IN PATIENTS WITH DISTAL MALIGNANT BILIARY OBSTRUCTION: AN ANALYSIS USING A COMPETING RISK MODEL. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 42(2), 276¿282. DOI: 10.1007/S00270-018-2107-9.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE FROM THE JOURNAL OF JOURNAL OF CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE (CIRSE) TITLED " PREDICTORS OF RECURRENT BILIARY OBSTRUCTION FOLLOWING PERCUTANEOUS UNCOVERED METAL STENT INSERTION IN PATIENTS WITH DISTAL MALIGNANT BILIARY OBSTRUCTION: AN ANALYSIS USING A COMPETING RISK MODEL " THAT IN A RETROSPECTIVE STUDY OF 119 PATIENTS, PROCEDURE-RELATED COMPLICATIONS WERE OCCURRED IN 18 PATIENTS. EARLY CHOLANGITIS IN 14 PATIENTS, ACUTE PANCREATITIS IN 2 PATIENTS, BILOMA IN 1 PATIENT, HEMOBILIA IN 1 PATIENT, AND RECURRENT JAUNDICE WAS OBSERVED IN 7 PATIENTS WITH AMPULLARY CANCER. EXTERNAL DRAINAGE CATHETER WAS PLACED IN 22 PATIENTS DUE TO PRE-PROCEDURE CHOLANGITIS, POOR BILIARY DRAINAGE, NON-FULLY EXPENDED STENT, OR HEMOBILIA AFTER STENTING. THE STATUS OF THE PATIENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116727 UNK E-LUMINEXX BILIARY STENT BILIARY STENT FGE ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R