BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 6847639 · Received September 7, 2017

    Report

    Report Number
    3001845648-2017-00386
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Report Date
    November 9, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002372778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. PMA/510(K) #K163169. THE ZIB6-40-10-8.0 DEVICE OF LOT NUMBER C1184122 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 OF THE DEVICE WERE PROVIDED. THE INVESTIGATION WILL BE UPDATED ONCE THE IMAGES HAVE BEEN EVALUATED BY A CLINICAL SPECIALIST. 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 A DIFFICULT PATIENT ANATOMY, WHICH COULD PLACE STRESS ON THE STENT. HOWEVER, THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE IMAGES ARE NOT YET EVALUATED AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT. THEREFORE, A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. 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 C1184122. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ACCORDING TO INFORMATION PROVIDED, THERE WAS NO ANY ADDITIONAL PROCEDURE OR ANY TREATMENT IN RELATION WITH THIS STENT FRACTURE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AFTER FEW WEEKS, THE STENT BROKE ITSELF IN THE BILIARY DUCTS OF THE PATIENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH THE INVESTIGATION CONCLUSIONS. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K) #K163169.

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PMA/510(K) #K163169. THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM FDA THAT INVESTIGATION INTO THIS EVENT IS COMPLETE AND THE CONCLUSION OF THIS INVESTIGATION HAS BEEN UPDATED. THE ZIB6-40-10-8.0 DEVICE OF LOT NUMBER C1184122 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: FIVE IMAGES ARE PROVIDED. FOUR ARE PHOTOGRAPHS FROM A MONITOR OF CT IMAGES. THE FIFTH IS A PHOTOGRAPH OF THE PROCEDURE DOCUMENT. THE PROCEDURE DOCUMENT INDICATES THAT THE STENT WAS IMPLANTED BY THE INTERVENTIONAL RADIOLOGY SERVICE EITHER (B)(6) 2016 OR (B)(6) 2016 AND THAT THE PATIENT HAD BEEN ADMITTED TO THE CANCER SERVICE. ONE AXIAL CT IMAGE WAS DATED (B)(6) 2016. ONE IMAGE WAS DATED (B)(6) 2017. THE REMAINING TWO IMAGES DID NOT INCLUDE DATES BUT GIVEN THE STENT'S APPEARANCE WERE LIKELY PERFORMED AFTER (B)(6) 2016. THE LEFT LOBE OF THE LIVER IS ABSENT ON ALL IMAGES. THE PRESENCE OF SURGICAL CLIPS IN THE REGION OF THE PORTA HEPATIS, THE SHAPE OF THE RIGHT LOBE OF THE LIVER AND THE ABSENCE OF FINDINGS INDICATING RECENT SURGERY WERE MOST CONSISTENT WITH A REMOTE LEFT HEPATECTOMY. AREAS OF DECREASED ENHANCEMENT CENTRALLY IN THE HEPATIC REMNANT SUGGEST TUMOR. 6CM OF THE 10X80MM STENT WAS IMAGED ON THE (B)(6) 2016 CT, EXTENDING FROM THE REGION OF THE PORTA HEPATIS LEFTWARD THROUGH A 2CM IN DIAMETER STRUCTURE HAVING THE APPEARANCE OF SMALL BOWEL AND NOT BILE DUCT. THIS STRUCTURE'S LENGTH AND ITS POSITION SUPERIOR TO THE PANCREATIC BODY AND ANTERIOR TO THE SMALL BOWEL MESENTERY INDICATE THAT IT COULD NOT BE NORMAL DUODENUM. IT WAS MOST CONSISTENT WITH A HEPATICOJEJUNOSTOMY NEAR THE RIGHT LOBE BILIARY DUCT CONFLUENCE AS NO SIGNIFICANT COMMON BILE DUCT REMNANT WAS SUGGESTED. THE IMAGE PERFORMED (B)(6) 2017 AND THE TWO UNDATED IMAGES SHOW STENT FRACTURE 3CM FROM THE RIGHT END OF THE STENT. THE REMAINING 5CM OF STENT WAS IN TWO PIECES, CONSISTING OF A 1CM CENTRAL FRAGMENT AND A 4CM LEFT FRAGMENT. ONE OF THE UNDATED IMAGES DEMONSTRATES ENHANCING SOFT TISSUE WITHIN THE RIGHT STENT FRAGMENT AND BILIARY DUCT DILATION. THIS PORTION OF THE STENT WAS LIKELY AT THE CHOLEDOCHOJEJUNOSTOMY. THE 40CM DELIVERY SYSTEM LENGTH INDICATES THAT THE STENT WAS PLACED PERCUTANEOUSLY EITHER THROUGH ROUX-EN-Y ACCESS LOOP OR TRANS-HEPATIC. IMPRESSION : STENT FRACTURE INTO THREE FRAGMENTS BETWEEN 3.25 MONTHS POST IMPLANTATION AND 13.5 MONTHS POST IMPLANTATION IS CONFIRMED. THE STENT APPEARS TO HAVE BEEN IMPLANTED PRIMARILY IN SMALL BOWEL WITH ONLY THE RIGHT END ACROSS A HEPATICOJEJUNOSTOMY. THE STENT LIKELY FRACTURED IN BOWEL. THE BEST FIT, ANATOMIC AND CLINICAL SCENARIO IS A REMOTE LEFT HEPATECTOMY AND ROUX-EN-Y ACCESS LOOP CHOLEDOCHOJEJUNOSTOMY, RECURRENT MALIGNANCY AT THE PORTA-HEPATIS, AND SUBSEQUENT STENT IMPLANTATION THROUGH PERCUTANEOUS ACCESS OF A ROUX-EN-Y ACCESS LOOP. THE PROVIDED IMAGING SUPPORTS STENT FRACTURE IN BOWEL AND NOT IN BILE DUCT. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE OBSERVED. A REMOTE LEFT HEPATECTOMY LIKELY HAD BEEN PERFORMED AND A HEPATICOJEJUNOSTOMY WITH THE RIGHT LOBE BILIARY DUCT CONFLUENCE LIKELY HAD BEEN PERFORMED. THE DIRECTION OF THE STENT CONTAINING BOWEL SUGGESTS AN ADDITIONAL ROUX-EN-Y PERCUTANEOUS ACCESS LOOP. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE OBSERVED. TUMOR NEAR AND IN THE PORTAHEPATIS WAS LIKELY. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. THE STENT LIKELY WAS IMPLANTED IN A ROUX-Y-LOOP WITH THE RIGHT END JUST EXTENDING ACROSS THE BILIARY ANASTOMOSIS. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED. THE STENT FRACTURED INTO THREE PIECES. THE FRACTURES LIKELY OCCURRED WITHIN BOWEL. CAUSE OF ADVERSE EVENTS WAS NOT OBSERVED. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGE(S). THE IMAGE REVIEW SHOWED THAT THE STENT WAS FRACTURED INTO THREE PIECES. PRODUCT DEVELOPMENT AND CLINICAL INPUT CONFIRMED THAT THE COMPLAINT DEVICE WAS USED AGAINST THE INDICATIONS OF USE. THE FOLLOWING COMMENTS WERE MADE: ¿THERE WAS A PORTION OF THE STENT STILL WITHIN THE BILIARY DUCT UPON DEPLOYMENT¿, BUT ACCORDING TO THE IMAGING REVIEW, ¿NO SIGNIFICANT COMMON BILE DUCT REMNANT WAS SUGGESTED¿ WHICH MEANS THE MAJORITY PORTION OF THE STENT MIGHT HAVE BEEN DEPLOYED INTO JEJUNUM (3 CM IN THE RESIDUAL BILE DUCT, 1CM+4CM IN BOWEL), WHICH IS CONSISTENT WITH THE FINDING THAT ¿THE STENT LIKELY FRACTURED IN BOWEL¿, THE PERISTALSIS OF JEJUNUM WOULD CONTRIBUTE TO THE MAJORITY STENT FRACTURES. IN NORMAL USAGE OF THE BILIARY STENT, MAJORITY OF STENT WILL BE DEPLOYED INTO THE BILIARY DUCT, ONLY APPROX. 0.5CM SHOULD EXTEND BEYOND PAPILLA AND INTO DUODENUM WHICH MINIMIZES THE IMPACT FROM DUODENUM PERISTALSIS.¿ POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE A DIFFICULT PATIENT ANATOMY AND THE USE OF THE DEVICE AGAINST THE INDICATED USE. FROM THE IMAGE REVIEW, IT IS KNOWN THAT THE PATIENT HAD A ROUX-EN-Y ACCESS LOOP CHOLEDOCHOJEJUNOSTOMY. THE IMAGE REVIEW SUGGESTED THAT THE PATIENT DID NOT HAVE A SIGNIFICANT COMMON BILE DUCT REMNANT. THIS WOULD INDICATE THAT 5CM OF THE STENT WOULD HAVE EXTENDED INTO THE JEJUNUM OF THE SMALL BOWEL. THE PERISTALSIS OF JEJUNUM COULD HAVE CAUSED OR CONTRIBUTED TO THE MAJORITY STENT FRACTURE. IT MAY BE NOTED THAT THE USE OF THE COMPLAINT DEVICE IN THE SMALL BOWEL IS AGAINST THE INDICATIONS OF USE. AS PER THE PRODUCT INSTRUCTIONS FOR USE: "THE ZILVER 518 AND 635 BILIARY STENTS ARE INTENDED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE." "STENTS BRIDGING THE PAPILLA SHOULD EXTEND NO MORE THAN 5 MM BEYOND THE PAPILLA AND INTO THE DUODENUM AFTER 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 C1184122. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ACCORDING TO INFORMATION PROVIDED, THERE WAS NO ANY ADDITIONAL PROCEDURE OR ANY TREATMENT IN RELATION WITH THIS STENT FRACTURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM FDA THAT INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. AN ADDITIONAL FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH THE INVESTIGATION CONCLUSIONS. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K) #K163169.

    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: AFTER FEW WEEKS, THE STENT BROKE ITSELF IN THE BILIARY DUCTS OF THE PATIENT.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM FDA THAT INVESTIGATION INTO THIS EVENT IS COMPLETE AND THE CONCLUSION OF THIS INVESTIGATION HAS BEEN UPDATED. INITIAL REPORT DETAILS: AFTER FEW WEEKS, THE STENT BROKE ITSELF IN THE BILIARY DUCTS OF THE PATIENT.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM FDA THAT INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. AN ADDITIONAL FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH THE INVESTIGATION CONCLUSIONS. INITIAL REPORT DETAILS: AFTER FEW WEEKS, THE STENT BROKE ITSELF IN THE BILIARY DUCTS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627688 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD 10827002372778

    Patients

    Seq Age Sex Outcome Treatment
    1