BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 6857908 · Received September 12, 2017

    Report

    Report Number
    3001845648-2017-00393
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    August 18, 2017
    Report Date
    September 14, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002372761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. THIS SPECIFIC ZILVER DEVICE IS CURRENTLY REGISTERED FOR SALE BUT NOT MARKETED IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENT/SETS (ZILVER) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PMA/510(K) #K040505/ K163169. THE ZIB6-40-10-6.0 DEVICE OF LOT NUMBER C1313627 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. IMAGES AND VIDEO OF THE PROCEDURE WERE PROVIDED BY THE CUSTOMER. THE INVESTIGATION WILL BE UPDATED ONCE THE IMAGES HAVE BEEN REVIEWED. THERE IS NO EVIDENCE TO SUGGEST THIS EVENT DID NOT OCCUR. THEREFORE, THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE PROCEDURAL METHOD. FROM CUSTOMER TESTIMONY, THE PHYSICIAN ATTEMPTED TO MOVE THE DELIVERY SYSTEM WHILE SIMULTANEOUSLY DEPLOYING THE STENT. THE STENT ENGAGED ON THE WALL OF THE BILIARY TRACT, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE STENT ELEMENTS FRACTURING. HOWEVER, THE DEVICE IS NOT AVAILABLE FOR EVALUATION, THE PROCEDURAL IMAGES HAVE NOT YET BEEN REVIEWED AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT. THEREFORE, A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. FROM THE PRODUCT INSTRUCTION FOR USE: ¿REPOSITIONING OF THE DEVICE AFTER DEPLOYMENT IS NOT POSSIBLE SINCE THE INTRODUCER CATHETER CANNOT BE RE-ADVANCED OVER THE STENT ONCE DEPLOYMENT BEGINS.¿ ALL ZIB6 (ZILVER 635 BILIARY DEVICES) ARE SUBJECT TO VISUAL AND FUNCTIONAL CHECKS. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED TO DATE, THERE IS NO EVIDENCE TO SUGGEST ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1313627. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE PHYSICIAN DELIVERED THE STENT TO THE LOCATION OF LESION ALONG THE WIRE GUIDE. BUT BECAUSE OF THE LOCATION WAS RELATIVELY CLOSE THE INTESTINAL TRACT, SO THE PHYSICIAN PULLED BACK THE STENT ABOUT 1 CM, SYNCHRONOUSLY, THE PHYSICIAN RELEASED THE STENT. THUS, THE WIRE OF THE STENT HOOKED THE WALL OF BILIARY TRACT AND CAUSED DEFORMATION. UNDER DSA FOUND THAT ONE WIRE AT THE DISTAL END OF TWO SIDES OF THE STENT WAS DETACHED. THE STENT WAS IMPLANTED IN THE PATIENT CAN NOT REMOVE OUT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT IS IN GOOD CONDITION. BUT THE RISK IS STILL POTENTIAL.

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS SPECIFIC ZILVER DEVICE IS CURRENTLY REGISTERED FOR SALE BUT NOT MARKETED IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENT/SETS (ZILVER) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PMA/510(K) #K040505/ K163169. THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. THE ZIB6-40-10-6.0 DEVICE OF LOT NUMBER C1313627 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. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: FINDINGS: TWO IMAGES AND ONE VIDEO DURING IMPLANTATION ARE PROVIDED ALONG WITH THE COMPLAINT REPORT. THE LEFT HEPATIC DUCT HAD BEEN ACCESSED PERCUTANEOUSLY AND A WIRE ADVANCED THROUGH THE COMMON BILE DUCT INTO THE DUODENUM. CONTRAST OPACIFIED THE DUODENUM AND AN ADJACENT LARGE DUODENAL DIVERTICULUM. INSTEAD OF THE DELIVERY SYSTEM BEING FIXED AS THE DELIVERY SHEATH WAS RETRACTED, THE DELIVERY SYSTEM WAS ADVANCED ON INITIAL DEPLOYMENT. AS THE DELIVERY SYSTEM TIP WAS ADVANCED, THE STENT END DID NOT IMMEDIATELY FOLLOW. SEPARATION DEVELOPED BETWEEN THE STENT AND THE DELIVERY SYSTEM TIP'S TRAILING EDGE. SIMULTANEOUSLY, A TUBULAR DENSITY BRIEFLY EXTENDED BEYOND THE OUTSIDE OF THE SHEATH AND THEN RETRACTED. UPON RETRACTION, THE DISTAL STENT ADVANCED ONE CENTIMETRE OUTSIDE THE SHEATH. AS SOON AS THE DISTAL STENT SECTION WAS COMPLETELY REVEALED, THREE STENT ELEMENTS FROM THE DISTAL SECTION EXTENDED FROM THE STENT, INDICATING A FRACTURE OF THE DISTAL STENT SECTION BETWEEN THE DISTAL AND FIRST FLEX CELL SECTIONS. CONSISTENT WITH THE COMPLAINT REPORT, THE STENT WAS THEN RETRACTED ONE CENTIMETER; HOWEVER, THE RETRACTION WAS HINDERED BY A FRACTURED SECTION'S ENTRAPMENT IN THE ADJACENT DUCT WALL. THE FRACTURED SECTION WAS PARTIALLY INVERTED AS THE STENT WAS RETRACTED, CONSTRICTING THE DISTAL STENT'S OPENING. INSTEAD OF SEPARATING, THE DISTAL STENT MARKERS WERE GATHERED INTO A CLUSTER. THIS, FORTUNATELY, DID NOT LIMIT DISTAL STENT EXPANSION BEYOND THE DIFFUSE DISTAL COMMON DUCT STENOSIS THAT CONSTRAINED THE STENT TO APPROXIMATELY 3MM EXPANSION. THE STENT'S DISTAL END WAS DEPLOYED JUST INSIDE THE EXPECTED LOCATION OF THE AMPULLA. THE DISTAL SECTION, FRACTURED END EXPANSION GREATER THAN 10MM INDICATES THAT THE STENT WAS DEPLOYED ACROSS THE AMPULLA INTO THE DUODENAL DIVERTICULUM. ONE IMAGE DEMONSTRATED TEMPORARY CONSTRAINT OF THE PROXIMAL STENT AS IT WAS DEPLOYED PARTIALLY INSIDE THE ACCESS SHEATH. THE SUBSEQUENT IMAGE DEMONSTRATED PROXIMAL STENT EXPANSION UPON ACCESS SHEATH RETRACTION. IMPRESSION: THE DISTAL STENT SECTION WAS FRACTURED EITHER BEFORE OR DURING DEPLOYMENT. STENT ADVANCEMENT AND SHEATH FIXATION RATHER THAN STENT FIXATION AND SHEATH RETRACTION LIKELY CAUSED STENT FRACTURE DURING DEPLOYMENT. THE STENT APPEARED TO TRANSIENTLY INTUSSUSCEPT, OR FOLD INSIDE ITSELF. THIS COULD ONLY OCCUR IF THE DISTAL STENT TRANSIENTLY WAS BOUND IN THE DELIVERY SHEATH WHILE THE DELIVERY SYSTEM INNER CANNULA WAS STILL ADVANCING THE PROXIMAL STENT. THIS WAS EVIDENT IN THE GAP BETWEEN THE STENT AND DELIVERY SYSTEM TIP AND THE TRANSIENT TUBULAR DENSITY EXTENDING BEYOND THE STENT WHICH COULD ONLY REPRESENT THE MORE PROXIMAL STENT. AS THE FRACTURE RELIEVED THE BINDING, THE DISTAL STENT SPRUNG OUT OF THE SHEATH. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE NOT OBSERVED. THE DISTAL STENT SECTION FRACTURE WAS ALLOWED TO FREELY EXPAND INTO A DUODENAL DIVERTICULUM ORIGINATING AT THE AMPULLA. THIS SHOULD REDUCE THE FRACTURE'S EROSION POTENTIAL. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. THE STENT WAS INITIALLY ADVANCED OUTSIDE TO THE DELIVERY SHEATH RATHER THAN BEING REVEALED. THIS LIKELY CAUSED THE STENT TO FRACTURE. IT IS VERY UNLIKELY THE STENT CAME FRACTURED. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE NOT OBSERVED. CAUSE OF ADVERSE EVENTS WAS NOT OBSERVED. COMPLAINT IS CONFIRMED STENT FRACTURE WAS OBSERVED IN THE IMAGE(S). POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE PROCEDURAL METHOD. FROM CUSTOMER TESTIMONY AND THE IMAGE REVIEW, THE PHYSICIAN ADVANCED THE DELIVERY SYSTEM DURING DEPLOYMENT THE STENT. THE STENT ENGAGED ON THE WALL OF THE BILIARY TRACT, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE STENT FOLDING ON ITSELF AND THE STENT ELEMENTS FRACTURING. HOWEVER, THE DEVICE IS NOT AVAILABLE FOR EVALUATION, AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT. THEREFORE, A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. FROM THE PRODUCT INSTRUCTION FOR USE: ¿REPOSITIONING OF THE DEVICE AFTER DEPLOYMENT IS NOT POSSIBLE SINCE THE INTRODUCER CATHETER CANNOT BE RE-ADVANCED OVER THE STENT ONCE DEPLOYMENT BEGINS.¿ ¿DO NOT ATTEMPT TO PUSH THE HANDLE AWAY FROM THE HUB DURING DEPLOYMENT.¿ ALL ZIB6 (ZILVER 635 BILIARY DEVICES) ARE SUBJECT TO VISUAL AND FUNCTIONAL CHECKS. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED TO DATE, THERE IS NO EVIDENCE TO SUGGEST ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1313627. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. INITIAL REPORT DETAILS: DURING THE PROCEDURE, THE PHYSICIAN DELIVERED THE STENT TO THE LOCATION OF LESION ALONG THE WIRE GUIDE. BUT BECAUSE OF THE LOCATION WAS RELATIVELY CLOSE THE INTESTINAL TRACT, SO THE PHYSICIAN PULLED BACK THE STENT ABOUT 1 CM, SYNCHRONOUSLY, THE PHYSICIAN RELEASED THE STENT. THUS, THE WIRE OF THE STENT HOOKED THE WALL OF BILIARY TRACT AND CAUSED DEFORMATION. UNDER DSA FOUND THAT ONE WIRE AT THE DISTAL END OF TWO SIDES OF THE STENT WAS DETACHED. THE STENT WAS IMPLANTED IN THE PATIENT CAN NOT REMOVE OUT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT IS IN GOOD CONDITION. BUT THE RISK IS STILL POTENTIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638927 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD 10827002372761

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR