BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 15657975 · Received October 24, 2022

    Report

    Report Number
    3001845648-2022-00712
    Event Type
    Injury
    Date Received
    October 24, 2022
    Date of Event
    January 10, 2022
    Report Date
    December 19, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 7X ZIMMON BILIARY STENT DEVICES OF UNKNOWN RPN AND LOT NUMBER INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO CAPTURE ' OFF LABEL USE AND MIGRATION' THE FOLLOWING FILES WERE ALSO RAISED FROM THE SAME JOURNAL ARTICLE: 376688 - JAGIELSKI ¿ OFF LABEL USE CST. 376690 - JAGIELSKI ¿ OFF LABEL USE ZIMMON STENT. 376691 - JAGIELSKI ¿ OFF LABEL USE NPDS. 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 MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BILIARY STENT PLACEMENT AS PER THE IFU : ¿THOSE ASSOCIATED WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE BILIARY TRACT OR DUODENUM, OBSTRUCTION OF THE PANCREATIC DUCT, STENT MIGRATION¿ UPON REVIEWING THE JOURNAL ARTICLE AND INITIAL CLINICAL INPUT RECEIVED FROM THE MEDICAL ADVISOR, IT WAS NOTED THAT THE DEVICES RELATING TO THIS COMPLAINT FILE WERE USED TO DRAIN PANCREATIC COLLECTIONS TRANSMURALLY. THIS IS CONSIDERED OFF LABEL USE AS THE DEVICES USED WERE TO DRAIN OBSTRUCTED BILIARY DUCTS, NOT PANCREATIC. AS PER THE INTENDED USE STATED IN THE IFU : "THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS.". THE IFU ALSO STATES IN THE NOTES SECTION: "DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE". WITH THE ABOVE INFORMATION, THERE IS EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF-LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE DEVICES INVOLVED WERE USED TO TRANSMURALLY DRAIN PANCREATIC COLLECTIONS INSTEAD OF DRAIN OBSTRUCTED BILIARY DUCTS AS PER ITS INTENDED USE. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE JOURNAL ARTICLE, THERE WERE 7 CASES OF TRANSMURAL STENT MIGRATION INTO THE LUMEN OF THE COLLECTION WHICH WAS TREATED ENDOSCOPICALLY. AS PER MEDICAL ADVISORS CLINICAL INPUT, THE MIGRATION REQUIRED INTERVENTION/ADDITIONAL PROCEDURES TO TREAT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    JAGIELSKI 2022 ¿ ¿EARLY ENDOSCOPIC TREATMENT OF SYMPTOMATIC PANCREATIC NECROTIC COLLECTIONS.¿ SINGLE TRANSLUMINAL GATEWAY TECHNIQUES (SGT): FISTULOTOMY WAS LOCATED WITH USE OF EUS. ENTEROSTOMY WAS PERFORMED USING CYSTOTOME (CYSTOTOME CST-10, COOK ENDOSCOPY). FISTULA BETWEEN THE GASTROINTESTINAL TRACT LUMEN AND NECROTIC COLLECTION WAS WIDENED USING A 15-MM HIGH-PRESSURE BALLOON (COOK ENDOSCOPY OR BOSTON SCIENTIFIC). THROUGH THE FISTULA, A LUMEN-APPOSING METAL STENT (LAMS) (DIAMETER, 16 MM; LENGTH, 30 OR 40 MM TAEWOONG MEDICAL OR OLYMPUS) WAS INSERTED TRANSMURALLY IN EACH CASE. SUBSEQUENTLY, THROUGH THE LAMS, 7- OR 8-FR NASAL DRAIN (COOK ENDOSCOPY) AND/OR A 7- OR 8.5-FR DOUBLE PIGTAIL ENDOSCOPIC STENT (COOK ENDOSCOPY) WERE INSERTED. MULTIPLE TRANSLUMINAL GATEWAY TECHNIQUES (MTGT): IN PATIENTS QUALIFIED FOR CREATION OF ANOTHER TRANSMURAL TRACT BETWEEN THE NECROTIC CAVITY AND THE GASTROINTESTINAL TRACT, THE SITE OF FISTULOTOMY WAS ALSO DETERMINED UNDER EUS GUIDANCE. ENTEROSTOMY WAS PERFORMED USING CYSTOTOME (CYSTOTOME CST-10, COOK ENDOSCOPY). THE FISTULA WAS DILATED USING A HIGH-PRESSURE 15-MM BALLOON (COOK ENDOSCOPY OR BOSTON SCIENTIFIC). SUBSEQUENTLY, A LAMS (DIAMETER, 16 MM; LENGTH, 30 OR 40 MM TAEWOONG MEDICAL OR OLYMPUS) WAS INSERTED TRANSMURALLY. THROUGH THE LAMS, A 7- OR 8-FR NASOCYSTIC DRAIN (COOK ENDOSCOPY) AND/OR A 7- OR 8.5-FR DOUBLE PIGTAIL ENDOSCOPIC STENT (COOK ENDOSCOPY) WERE INSERTED INTO THE NECROTIC COLLECTION. SINGLE TRANSLUMINAL GATEWAY TRANSCYSTIC MULTIPLE DRAINAGE (SGTMD): IN PATIENTS QUALIFIED FOR SGTMD SUB-SEQUENT ENDOSCOPIC PROCEDURES WERE PERFORMED AND A GUIDEWIRE WAS INTRODUCED IN THE NECROTIC SUBCAVITIES WITH FLUOROSCOPY GUIDANCE THROUGH THE TRANSMURAL TRACT CREATED BETWEEN THE NECROTIC COLLECTION AND THE GASTROINTES-TINAL LUMEN. THE CANALS BETWEEN THE NECROTIC SUBCAVITIES WERE DILATED WITH A 8-MM HIGH-PRESSURE BALLOON (BOS-TON SCIENTIFIC) UNDER FLUOROSCOPY AND ENDOSCOPY GUIDANCE. SUBSEQUENTLY, ANOTHER 7- OR 8-FR NASAL DRAIN (COOK ENDOSCOPY) AND/OR 7- OR 8.5-FR DOUBLE PIGTAIL STENT (COOK ENDOSCOPY) WERE INTRODUCED THROUGH THOSE CANALS AND THEIR DISTAL ENDS WERE DEPLOYED WITHIN NECROTIC SUBCAVITIES. DIRECT ENDOSCOPIC NECROSECTOMY (DEN)15. THE NASAL DRAIN WAS REMOVED AND THE GASTROSCOPE WAS INSERTED INTO THE NECROTIC COLLECTION THROUGH THE TRANSMURAL STENT. THE COLLECTION WAS FLUSHED SEVERAL TIMES WITH SALINE AND THE NECROTIC CONTENT WAS REMOVED. USING A 15¿20-MM EXTRACTION BALLOON (COOK ENDOSCOPY) AND DORMIA BASKET (COOK ENDOSCOPY OR OLYMPUS), THE NECROTIC TISSUES WERE REMOVED UNDER DIRECT ENDOSCOPIC GUIDANCE. THE PROCEDURE WAS REPEATED MULTIPLE TIMES DURING EACH NECROSECTOMY SESSION. SUBSEQUENTLY, A NASAL DRAIN AND/OR DOUBLE PIGTAIL PLASTIC STENT WERE INSERTED TRANSMURALLY INTO THE NECROTIC COLLECTION. PER TABLE 4 THERE WAS 7 CASES OF TRANSMURAL STENT MIGRATION INTO LUMEN OF THE COLLECTION (TREATED ENDOSCOPICALLY). THE USE OF A 7- OR 8.5-FR DOUBLE PIGTAIL ENDOSCOPIC STENT TO DRAIN PANCREATIC COLLECTION TRANSMURALLY IS CONSIDERED OFF-LABEL USE. THIS FILE WILL CAPTURE THE 7 CASES OF OFF LABEL USE AND TRANSMURAL STENT MIGRATION. TREATED ENDOSCOPICALLY REQUIRE INTERVENTION/ADDITIONAL PROCEDURES.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2022 AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2821561 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention