BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 16371240 · Received February 14, 2023

    Report

    Report Number
    3001845648-2023-00100
    Event Type
    Injury
    Date Received
    February 14, 2023
    Date of Event
    July 22, 2021
    Report Date
    May 4, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163018. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO (B)(4) (EMDR REF.- 3001845648-2023-00099) AND (B)(4) (EMDR REF.- 3001845648-2023-00103) AND IT WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE REF. ATT. ¿KUMAR - SURVIVAL.PDF¿. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZIB DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE LISTS STENT OCCLUSION AS A POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU OR LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS. FROM THE ARTICLE IT IS KNOW THAT THE PATIENTS IN THE BILIARY STENTING GROUP HAD THE FOLLOWING PRE-EXISTING CONDITIONS: 05 CASES GALL BLADDER CANCER, 04 CASES PERIAMPULLARY MASS, 01 CASE CHOLANGIOCARCINOMA. IT IS POSSIBLE THAT TUMOUR INGROWTH MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT OF STENT OCCLUSION. AS PREVIOUSLY NOTED, THE IFU LISTS STENT OCCLUSION AS A POTENTIAL ADVERSE EVENT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER KUMAR ET AL ¿SURVIVAL BENEFIT OF PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE FOR MALIGNANT BILIARY TRACT OBSTRUCTION ¿ A PROSPECTIVE STUDY COMPARING EXTERNAL AND INTERNAL DRAINAGE TECHNIQUES¿. ACCORDING TO THE INITIAL REPORTER, THE PATIENT WAS TREATED BY INSERTION OF A BALLOON CATHETER THROUGH THE STENT. AS PER MEDICAL ADVISOR INPUT ¿REQUIRE INTERVENTION/ADDITIONAL PROCEDURES¿ COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    KUMAR 2021 - SURVIVAL BENEFIT OF PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE FOR MALIGNANT BILIARY TRACT OBSTRUCTION¿A PROSPECTIVE STUDY COMPARING EXTERNAL AND INTERNAL DRAINAGE TECHNIQUES. STANDARD US AND FLUOROSCOPY GUIDED TECHNIQUES WERE USED TO INSERT SINGLE 8 FR EXTERNAL BILIARY DRAINAGE CATHETER (DEVON INNOVATIONS, (B)(4) INDIA), 8.3 OR 10.2 FR INTERNAL-EXTERNAL RING BILIARY CATHETER (COOK, (B)(4) IN, USA) OR 10 MM DIAMETER ZILVER SELF-EXPANDING METALLIC STENT (COOK, (B)(4) IN, USA). BILIARY RADICLE PUNCTURE WAS DONE USING 18G PUNCTURE NEEDLE UNDER US GUIDANCE (B)(4) GE HEALTHCARE, USA) AND AFTER INSERTION OF A 5FR SHEATH (COOK, (B)(4) IN, USA) USING SELDINGER¿S TECHNIQUE, A 4FR MPA, C1 OR JR4 CATHETER (CORDIS, MIAMI, USA) WAS MANIPULATED ACROSS THE OBSTRUCTION OVER A 0.035 INCH NITINOL HYDROPHILIC GUIDEWIRE (B)(4) EUROPE) UNDER FLUOROSCOPIC GUIDANCE, AN AMPLATZ EXTRASTIFF GUIDEWIRE (COOK, (B)(4) IN, USA) WAS EXCHANGED AND AFTER SERIAL DILATATION WITH FASCIAL DILATORS (COOK, (B)(4) IN, USA), THE DEVICE WAS PLACED. ALL PATIENTS WERE OFFERED RING BILIARY CATHETER OR STENT PLACEMENT DURING THE CONSENT PROCESS; HOWEVER, IF CHOLANGITIS WAS PRESENT OR IN FAILURE TO CROSS THE OBSTRUCTION, AN EXTERNAL DRAINAGE CATHETER WAS INITIALLY PLACED AND SUBSEQUENTLY RING BILIARY CATHETER OR STENT WAS DEPLOYED. REPEAT INTERVENTIONS WERE DONE FOR DEVICE UPGRADATIONS OR DEVICE-RELATED ISSUES VIZ. BLOCKAGE, EXTENSIVE SOILING, BROKEN CATHETER HUB, ACCIDENTAL SLIPPAGE OR DISLODGEMENT OF THE CATHETER. ONE CASE OF STENT HAD BLOCKAGE AT 11 MONTHS AND WAS TREATED BY INSERTION OF RING BILIARY CATHETER THROUGH THE STENT. PATIENT OUTCOME: REQUIRE INTERVENTION/ADDITIONAL PROCEDURES. PATIENT/EVENT INFO - NOTES : MEAN AGE: 33 YEARS. GENDER: 7 MALE, 2 FEMALE.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798310 ZILVER 635 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Required Intervention