BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 15666181 · Received October 25, 2022

    Report

    Report Number
    3001845648-2022-00719
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    November 25, 2021
    Report Date
    April 14, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE 1X ZIMMON BILIARY STENT DEVICE OF UNKNOWN RPN AND LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED IN RESPONSE TO THE JOURNAL ARTICLE ¿ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE IN THE MANAGEMENT OF POSTOPERATIVE PANCREATIC FISTULA AFTER PARTIAL PANCREATECTOMY¿ TO CAPTURE BLOCKAGE OF STENT. PR (B)(4) (3001845648-2022-00718) - WANG 2021 - ¿OFF LABEL USE CST-10 ¿ WAS ALSO RAISED FROM THIS LITERATURE ARTICLE. LAB EVALUATION: THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL 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 REVIEW HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IFU & LABEL REVIEW IT SHOULD BE NOTED THAT STENT OCCLUSION IS A KNOWN RISK AS PER THE MEDICAL ADVISOR¿S CLINICAL INPUT. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE OR PRODUCT LABEL. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. HOWEVER, STENT OCCLUSION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BILIARY STENT PLACEMENT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE JOURNAL ARTICLE, THE PATIENT EXPERIENCED THE STENT OCCLUSION ON THE 10TH DAY POST-PROCEDURE WITH COMPLAINTS OF RECURRENT ABDOMINAL PAIN AND FEVER. THE OCCLUDED STENT WAS REMOVED ENDOSCOPICALLY BY SNARE WITH A REPLACEMENT DEVICE INSERTED IN ITS PLACE. IN THE FOLLOWING DAYS, THE SYMPTOMS HAD RESOLVED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    WANG, 2021, ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE IN THE MANAGEMENT OF POSTOPERATIVE PANCREATIC FISTULA AFTER PARTIAL PANCREATECTOMY. ALL EUS-GUIDED PROCEDURES WERE PERFORMED WITH THERAPEUTIC LINEAR ARRAY ECHOENDOSCOPES (UCT-260, OLYMPUS,TOKYO, JAPAN) UNDER CONSCIOUS SEDATION ANESTHESIA BY TWO EXPERIENCED ENDOSCOPISTS. PERIPANCREATIC FLUID COLLECTION WAS LOCALIZED BY ULTRASOUND ENDOSCOPY. AFTER EXCLUDING THE PRESENCE OF LOCAL BLOOD VESSELS BY USING COLOR DOPPLER, A 19G PUNCTURE NEEDLE (ECHO-19, COOK IRELAND LTD., LIMERICK, IRELAND) WAS USED TO PUNCTURE THROUGH THE GASTRIC WALL AND INTO THE FLUID COLLECTION UNDER EUS-GUIDANCE. FLUID WAS ASPIRATED TO CONFIRM THAT THE NEEDLE TIP WAS IN THE CAVITY. A 0.035-INCH GUIDEWIRE (JAGWIRE, BOSTON SCIENTIFIC CORPORATION, UNITED STATES) WAS INTRODUCED THROUGH THE NEEDLE AND COILED WITHIN THE FLUID COLLECTION UNDER FLUOROSCOPIC GUIDANCE. THEN, THE PUNCTURE NEEDLE WAS WITHDRAWN, AND A COOK CYSTOTOME (CST-10, COOK IRELAND LTD.) WAS USED TO PUNCTURE THE GASTRIC WALL AND DILATE THE SINUS ALONG THE GUIDEWIRE. ANOTHER GUIDEWIRE WAS INSERTED ALONG THE CYSTOTOME. A 7FR-7 OR 7FR-3 DOUBLE-PIGTAIL PLASTIC STENT (ZIMMON BILIARY STENT, COOK IRELAND LTD.) WAS DEPLOYED. THE DISTAL END OF THE STENT WAS GENTLY PUSHED INTO THE CYSTIC CAVITY. NEXT, A NASOCYSTIC TUBE (NBDS-B-7/250-P, MICRO-TECH (NANJING) CO., LTD., NANJING, CHINA) WAS INSERTED INTO THE CAVITY. IF ANOTHER STENT WAS NEEDED, ONE MORE GUIDEWIRE WAS INSERTED, AND THE NASOCYSTIC TUBE WAS USUALLY INSERTED AFTER STENT INSERTION. ONE PATIENT (7%) UNDERWENT 7 FR DOUBLE-PIGTAIL PLASTIC STENT BLOCKAGE, ON THE 10TH DAY AFTER THE PROCEDURE. HE COMPLAINED OF RECURRENT ABDOMINAL PAIN AND FEVER, AND THE NASOCYSTIC DRAINAGE HAD LESS FLUID THAN BEFORE. THEREFORE, THE BLOCKED STENT WAS REMOVED BY USING A SNARE, AND ANOTHER 10 FR STENT (ZIMMON BILIARY STENT, COOK IRELAND LTD., LIMERICK, IRELAND) WAS INSERTED UNDER EUS GUIDANCE. THE NASOCYSTIC TUBE WAS ASPIRATED, BUT NOT FLUSHED. IN THE FOLLOWING DAYS, THE SYMPTOMS RESOLVED, AND ALL THE TEST RESULTS IMPROVED. INTERVENTION REQUIRED TO TREAT BLOCKAGE.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 14-APR-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2656469 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention