BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER BILIARY SELF-EXPANDING STENT

    MDR report key: 9389351 · Received November 28, 2019

    Report

    Report Number
    3001845648-2019-00634
    Event Type
    Injury
    Date Received
    November 28, 2019
    Report Date
    February 10, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. PMA/510(K) #: ZILVER BILIARY K182980 K163018.

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: ZILVER BILIARY K182980 K163018. DEVICE EVALUATION: THE UNKNOWN DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT, AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE INVESTIGATION FOR THIS FILE HAS BEEN BASED ON A ZIB DEVICE AS IT IS KNOWN THAT A COOK BILIARY STENT WAS USED DURING THE PROCEDURES MENTIONED IN THE ARTICLE. DOCUMENT REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ZIB DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0040-6). ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE CAUSED AND/OR CONTRIBUTED TO THE DEVELOPMENT OF CHOLANGITIS IN THE PATIENT. IT IS THEREFORE NOT POSSIBLE TO ASSIGN A FAILURE MODE AND EFFECT TO THIS FILE TO ASSESS IT FOR RISK. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE UNCOVERED NITINOL SEMSS (COOK INC., BLOOMINGTON,IN, UNITED STATES) WERE IMPLANTED. THROUGH AN 8F SHEATH, A DIRECTIONAL CATHETER IN COMBINATION WITH A HYDROPHILIC GUIDE WIRE WAS USED TO CROSS THE BILIARY OBSTRUCTION AND ADVANCED INTO THE SMALL BOWEL. AN APPROPRIATELY SIZED STENT MAY BE INSERTED, USUALLY 8 OR 10MM IN DIAMETER AND 40 TO 100MMIN LENGTH. ACCORDING TO THE DEGREE OF BILIARY STENOSIS AND STENT EXPANSION, PRE- OR POST DILATION WITH BALLOON CATHETER WAS SELECTED. CHOLANGIOGRAPHY VIA THE SHEATH AFTER STENT DEPLOYMENT WAS USED TO ASSESS STENT PATENCY. IN CASE OF SATISFACTORY CONTRAST AGENT FLOW, THE SHEATH WAS REMOVED, WITH THE PUNCTURE TRACT PLUGGED WITH GEL FOAM PLEDGES. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 AS THE PATIENTS EXPERIENCED CHOLANGITIS AND WOULD REQUIRE INTERVENTION/ADDITIONAL PROCEDURES.

    Description of Event or Problem · 0

    A TOTAL OF 156 PATIENTS WERE TREATED DURING THE STUDY PERIOD, INCLUDING 94 MEN (65.6 ± 11.4 YEARS OLD) AND 62 WOMEN (68.6 ± 12.0 YEARS OLD). BILIARY OBSTRUCTIONS IN THESE PATIENTS WERE PANCREATIC CANCER (N = 72), CHOLANGIOCARCINOMA (N = 40), MALIGNANT GASTRIC CARCINOMA (N = 21), CANCER OF THE AMPULLA OF VATER (N = 10), GALLBLADDER CARCINOMA (N = 7), COLON CANCER METASTASIS (N = 3), LUNG CANCER METASTASIS (N = 2), AND OVARY CANCER METASTASIS (N = 1). ALL PATIENTS HAD ¿DISTAL¿ BILIARY OBSTRUCTION. THE UNCOVERED NITINOL SEMSS (COOK INC., BLOOMINGTON,IN, UNITED STATES) WERE IMPLANTED. THROUGH AN 8F SHEATH, A DIRECTIONAL CATHETER IN COMBINATION WITH A HYDROPHILIC GUIDE WIRE WAS USED TO CROSS THE BILIARY OBSTRUCTION AND ADVANCED INTO THE SMALL BOWEL. AN APPROPRIATELY SIZED STENT MAY BE INSERTED, USUALLY 8 OR 10MM IN DIAMETER AND 40 TO 100MMIN LENGTH. ACCORDING TO THE DEGREE OF BILIARY STENOSIS AND STENT EXPANSION, PRE- OR POSTDILATION WITH BALLOON CATHETER WAS SELECTED. CHOLANGIOGRAPHY VIA THE SHEATH AFTER STENT DEPLOYMENT WAS USED TO ASSESS STENT PATENCY. IN CASE OF SATISFACTORY CONTRAST AGENT FLOW, THE SHEATH WAS REMOVED, WITH THE PUNCTURE TRACT PLUGGED WITH GEL FOAM PLEDGES.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    THE UNCOVERED NITINOL SEMSS (COOK INC., BLOOMINGTON,IN, UNITED STATES) WERE IMPLANTED. THROUGH AN 8F SHEATH, A DIRECTIONAL CATHETER IN COMBINATION WITH A HYDROPHILIC GUIDE WIRE WAS USED TO CROSS THE BILIARY OBSTRUCTION AND ADVANCED INTO THE SMALL BOWEL. AN APPROPRIATELY SIZED STENT MAY BE INSERTED, USUALLY 8 OR 10MM IN DIAMETER AND 40 TO 100MMIN LENGTH. ACCORDING TO THE DEGREE OF BILIARY STENOSIS AND STENT EXPANSION, PRE- OR POSTDILATION WITH BALLOON CATHETER WAS SELECTED. CHOLANGIOGRAPHY VIA THE SHEATH AFTER STENT DEPLOYMENT WAS USED TO ASSESS STENT PATENCY. IN CASE OF SATISFACTORY CONTRAST AGENT FLOW, THE SHEATH WAS REMOVED, WITH THE PUNCTURE TRACT PLUGGED WITH GEL FOAM PLEDGES. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 AS THE PATIENTS EXPERIENCED CHOLANGITIS AND WOULD REQUIRE INTERVENTION/ADDITIONAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184909 ZILVER BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention