BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 6401887 · Received March 14, 2017

    Report

    Report Number
    3001845648-2017-00089
    Event Type
    Malfunction
    Date Received
    March 14, 2017
    Date of Event
    February 13, 2017
    Report Date
    August 4, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002362458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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 ZIB6-125-14.0-60 DEVICE OF LOT C1069673 WAS IMPLANTED IN THE PATIENT, AND IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. IMAGES OF THE COMPLAINT DEVICE WERE PROVIDED BY THE CUSTOMER. HOWEVER, AT THE TIME OF THE INVESTIGATION, THE IMAGES HAVE NOT YET BEEN REVIEWED. THE INVESTIGATION WILL BE UPDATED WHEN THE IMAGES HAVE BEEN REVIEWED. AS PER THE INFORMATION PROVIDED BY THE DISTRICT MANAGER: "THE REPORT WAS FROM THE PATIENT RETURNING TO GET IVC FILTER REMOVED, THE FRACTURED STENT WAS NOTICED UPON NEAR FILTER RETRIEVAL. THE PATIENT IS NOT SHOWING ANY SYMPTOMS." "I WAS ABLE TO LOOK ON HIS MONITORS IN THE READING ROOM WHERE YOU HAVE THE CAPABILITIES OF MAGNIFYING THE IMAGE. IT IS CLEAR THAT IN THE EXACT LOCATION OF THE COMPRESSED VEIN/LESION THAT THE ZILVER 14 X 60 STENT¿S STRUTS WERE ACCOMMODATING THE VEIN BUT PUT IN A COMPROMISING POSITION AND OVER EXTENDING THE EXPECTATION OF THE STENT." FROM CUSTOMER TESTIMONY, THE COMPLAINT DEVICE WAS IMPLANTED TO TREAT MAY-THURNER SYNDROME IN THE LEFT COMMON ILIAC VEIN. THE PHYSICIAN ALSO NOTED THAT THE COMPLAINT STENT WAS SUBJECT TO STRESS DUE TO THE HIGHLY STENOTIC LESION. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT MAY BE NOTED THAT ZIB6 (ZILVER 635 BILIARY) STENTS ARE INDICATED FOR USE IN THE BILIARY TREE. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE PATIENT ANATOMY AS THE STENT WAS SUBJECT TO STRESS DUE TO THE STENOTIC LESION, AND/OR THE USE IN THE NON-INDICATED LOCATION (ILIAC VEINS). THESE FACTORS COULD HAVE CAUSED OR CONTRIBUTED TO THE STENT FRACTURE. HOWEVER, PROCEDURAL IMAGES HAVE NOT YET BEEN EVALUATED, AND THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT. THEREFORE, A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. FROM THE PRODUCT IFU: ¿THE ZILVER 518 AND 635 BILIARY STENTS ARE INTENDED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE¿. 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 C1069673. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. AT THE TIME OF THE INVESTIGATION, NO INFORMATION WAS PROVIDED REGARDING ADDITIONAL PROCEDURES. ACCORDING TO INFORMATION PROVIDED, THE PATIENT'S VEIN IS PATENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    ON (B)(6) 2017 THE PATIENT HAD AN OPTION FILTER PLACED AND RECEIVED LYSIS OVERNIGHT. PATIENT BROUGHT BACK (B)(6) 2017 AND HAD PROCEDURE TO THE LEFT COMMON ILIAC TO TREAT MAY THURNERS. A 14X80 ZILVER 635 WAS PLACED AND IT DID NOT COVER ALL OF THE LESION. AFTER BALLOONING, THERE WAS A NEED FOR A ADDITIONAL STENT AND A ZILVER 635 14X60 WAS PLACED. BALLOONED POST STENT AND COMPLETED. (B)(6) 2017 THE PATIENT WAS BROUGHT BACK FOR FILTER RETRIEVAL AND IT WAS NOTICED THAT THE 14X60 STENT WAS FRACTURED AND ATTACHED BY JUST A FEW STRANDS. AFTER REVIEWING THE (B)(6) 2017 FILMS WITH THE PHYSICIAN, IT WAS NOTICED THAT WHEN THE 14X60 STENT WAS PLACED, THE STENT WAS PUT UNDER THE STRESS DUE TO THE HIGHLY STENOTIC LESION. THIS WAS NOT SEEN WHEN INITIALLY PLACED. QUESTION REMAINS ON NEXT STEPS AND VASCULAR SURGERY HAS BEEN CONSULTED. FILTER RETRIEVAL WAS ABORTED.

    Additional Manufacturer Narrative · 1

    COOK (B)(4) (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PMA/510(K) # K163169. THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. THE ZIB6-125-14.0-60 DEVICE OF LOT C1069673 WAS IMPLANTED IN THE PATIENT, AND IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. AS PER THE INFORMATION PROVIDED BY THE DISTRICT MANAGER: "THE REPORT WAS FROM THE PATIENT RETURNING TO GET IVC FILTER REMOVED, THE FRACTURED STENT WAS NOTICED UPON NEAR FILTER RETRIEVAL. THE PATIENT IS NOT SHOWING ANY SYMPTOMS." "I WAS ABLE TO LOOK ON HIS MONITORS IN THE READING ROOM WHERE YOU HAVE THE CAPABILITIES OF MAGNIFYING THE IMAGE. IT IS CLEAR THAT IN THE EXACT LOCATION OF THE COMPRESSED VEIN/LESION THAT THE ZILVER 14 X 60 STENT¿S STRUTS WERE ACCOMMODATING THE VEIN BUT PUT IN A COMPROMISING POSITION AND OVER EXTENDING THE EXPECTATION OF THE STENT. FROM CUSTOMER TESTIMONY, THE COMPLAINT DEVICE WAS IMPLANTED TO TREAT MAY-THURNER SYNDROME IN THE LEFT COMMON ILIAC VEIN. THE PHYSICIAN ALSO NOTED THAT THE COMPLAINT STENT WAS SUBJECT TO STRESS DUE TO THE HIGHLY STENOTIC LESION. 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: IMPLANTATION ANGIOGRAPHY, ONE MONTH FOLLOW-UP ANGIOGRAPHY, AND A ONE MONTH FOLLOW-UP CT IS PROVIDED ALONG WITH THE COMPLAINT REPORT. A SINGLE ULTRASOUND IMAGE OF THE INTERNAL JUGULAR VEIN WAS ALSO PROVIDED. THE IVC OPTION FILTER WAS REPORTED IMPLANTED THE PRECEDING DAY. IT MIGRATED 13MM INFERIORLY ON FOLLOW UP ANGIOGRAPHY AND CT. THE SECOND STENT, A ZILVER 14X60MM, WAS IMPLANTED TO RESOLVE A RESIDUAL SEVERE LEFT COMMON ILIAC VEIN (CIV) ORIGIN STENOSIS. THE ZILVER 14X80MM HAD BEEN IMPLANTED SHORT OF SPANNING THE ENTIRE STENOSIS. THE SECOND STENT APPEARED NORMAL AFTER IMPLANTATION EXCEPT THAT THE PROXIMAL END TERMINATED AT THE OPTION FILTER BASE. THE FOLLOW UP ANGIOGRAPHY WAS PERFORMED TO REMOVE THE OPTION FILTER AND CONTINUED TO THE POINT AT WHICH THE FILTER WAS SNARED AND COVERED WITH THE SHEATH. FILTER REMOVAL WAS ABORTED EITHER BECAUSE THE STENT DEFORMITY WAS FIRST NOTICED OR THE STENT MOVED WITH THE SHEATH AS FILTER CAPTURE WAS ATTEMPTED. THE STENT WAS STRETCHED BEGINNING 13MM FROM ITS PROXIMAL END TO THE POINT WHERE IT ENTERED THE CIV. ONE OR TWO FRACTURED STENT ELEMENTS WERE LIKELY BUT NOT SPECIFICALLY RESOLVABLE ON THE LIMITED RESOLUTION IMAGING RECEIVED. HOWEVER, THE OVERALL DEFORMITY WAS PRIMARILY STRETCH AND NOT FRACTURE MEDIATED. FOLLOW UP CT DEMONSTRATES THE RIGHT POSTERIOR LEG EXTENSION THROUGH THE PROXIMAL MOST STENT ROW. IMPRESSION : ZILVER STENT STRETCHING IS CONFIRMED. FRACTURE OF A FEW STENT ELEMENTS WAS LIKELY BUT NOT DEFINITELY VISIBLE. THE STENT WAS ENTRAPPED IN THE OPTION FILTER WHEN THE FILTER MIGRATED INFERIORLY. THE STENT WAS STRETCHED AND LIKELY FRACTURED BY THE TRACTION EXERTED DURING RESPIRATORY EXCURSION. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. THE STENT WAS IMPLANTED IMMEDIATELY INFERIOR A RECENTLY DEPLOYED OPTION FILTER THAT MIGRATED INFERIORLY 13MM. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE NOT OBSERVED. CAUSE OF ADVERSE EVENTS WAS NOT OBSERVED. THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY AND AS THE IMAGE REVIEW STATED THAT FRACTURE OF A FEW ELEMENTS WAS LIKELY. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE MIGRATION OF THE OPTION FILTER. THE STENT WAS ENTRAPPED IN THE OPTION FILTER WHEN THE FILTER MIGRATED INFERIORLY. THE STENT WAS STRETCHED AND LIKELY FRACTURED BY THE TRACTION EXERTED DURING RESPIRATORY EXCURSION. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. FROM THE PRODUCT IFU: ¿THE ZILVER 518 AND 635 BILIARY STENTS ARE INTENDED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE¿. 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 C1069673. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. AT THE TIME OF THE INVESTIGATION, NO INFORMATION WAS PROVIDED REGARDING ADDITIONAL PROCEDURES. ACCORDING TO INFORMATION PROVIDED, THE PATIENT'S VEIN IS PATENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE 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: ON (B)(6) 2017 THE PATIENT HAD AN OPTION FILTER PLACED AND RECEIVED LYSIS OVERNIGHT. PATIENT BROUGHT BACK (B)(6) 2017 AND HAD PROCEDURE TO THE LEFT COMMON ILIAC TO TREAT MAY THURNERS. A 14X80 ZILVER 635 WAS PLACED AND IT DID NOT COVER ALL OF THE LESION. AFTER BALLOONING, THERE WAS A NEED FOR A ADDITIONAL STENT AND A ZILVER 635 14X60 WAS PLACED. BALLOONED POST STENT AND COMPLETED. (B)(6) 2017 THE PATIENT WAS BROUGHT BACK FOR FILTER RETRIEVAL AND IT WAS NOTICED THAT THE 14X60 STENT WAS FRACTURED AND ATTACHED BY JUST A FEW STRANDS. AFTER REVIEWING THE (B)(6) 2017 FILMS WITH THE PHYSICIAN, IT WAS NOTICED THAT WHEN THE 14X60 STENT WAS PLACED, THE STENT WAS PUT UNDER THE STRESS DUE TO THE HIGHLY STENOTIC LESION. THIS WAS NOT SEEN WHEN INITIALLY PLACED. QUESTION REMAINS ON NEXT STEPS AND VASCULAR SURGERY HAS BEEN CONSULTED. FILTER RETRIEVAL WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187246 ZILVER 635 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G36245 10827002362458

    Patients

    Seq Age Sex Outcome Treatment
    1