BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF EXPANDING BILIARY STENT

    MDR report key: 3955555 · Received June 13, 2014

    Report

    Report Number
    3001845648-2014-00105
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K040505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K): K043481 AND K051124. THE DEVICE INVOLVED IN THIS COMPLAINT IS: 1 X ZIB6-40-10-8.0 (LOT#C967907). THE STENT WAS IMPLANTED IN THE PT AND HENCE IS NOT AVAILABLE FOR EVAL. WITH THE INFO PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. A REVIEW OF THE MFG RECORDS FOR ZIB6-80-14.0-40 DEVICES AND ASSOCIATED STENTS DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION, ZILVER 635 BILIARY DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICES INTEGRITY. IMAGES WERE PROVIDED AND REVIEWED. THE OUTCOME OF THE IMAGE REVIEW WAS AS FOLLOWS: FINDINGS: THREE IMAGES FROM A COMPLICATED BILIARY PALLIATIVE DRAINAGE PROCEDURE ARE PROVIDED. A DILATED BILIARY TREE IS DRAINED BY THE VISIBLE DRAINAGE CATHETER FROM A RIGHT DUCT. THE CATHETER IS PIGTAILED IN A MORE CENTRAL RIGHT DUCT. THIS LIKELY IS A DAWSON-MUELLER CATHETER. THE DILATED PROXIMAL LEFT DICT IS FAINTLY SEEN. A SECOND DILATED RIGHT DUCT HAS BEEN STENTED FROM THE DUCT, ACROSS THE BILIARY CONFLUENCE INTO THE COMMON BILE DUCT (CBD). THE STENT IS NARROWED AND SEVERELY TORTUOUS AT THE CONFLUENCE SECONDARY TO NORMAL ANGLES EXAGGERATED BY A MASS DISTORTING THE CONFLUENCE. A WIRE IS IMAGED THROUGH THE STENT CONTAINING AN UNEXPECTED ANGIOPLASTY BALLOON. THE STENT APPEARS INTACT BUT DETAIL IS LIMITED. WIRE PURCHASE INTO THE DUODENUM IS VERY LIMITED. ANOTHER IMAGE SHOWS THE BALLOON FURTHER ADVANCED INTO THE STENT BUT ARCHING SUPERIORLY OUTSIDE THE STENT INTO THE BILIARY CONFLUENCE. THE BALLOON WAS STILL PROXIMAL THE NARROWED AND SEVERELY ANGULATED STENT SEGMENT. THE FINAL IMAGE DEMONSTRATES AN ATTEMPT TO RESTENT THE SEGMENT. THE SHEATH HAS BEEN ADVANCED TO THE NARROWED AND TORTUOUS SEGMENT BUT NOT BEYOND. THE STENT IS STILL INSIDE THE SHEATH. THE AMOUNT OF GUIDEWIRE PURCHASE INTO THE DUODENUM IS STILL MINIMAL. IMPRESSION: THE GUIDEWIRE/BALLOON COMBINATION AND ACCESS SHEATH GUIDEWIRE COMBINATION ARE OUTSIDE THE MID STENT WALL. THIS WAS CAUSED EITHER BY LOSS OF ACCESS FOLLOWED BY TRANSGRESSION OF STENT INTERSTICES UPON RECATHETERISATION OR BY PUSHING THE DRAINAGE CATHETER THROUGH THE STENT SUPERIOR WALL WHEN ATTEMPTING TO ADVANCE THE DRAIN THROUGH THE TORTUOUS AND STENOTIC STENTED SEGMENT. GIVEN THE COMPLAINT REPORT NARRATIVE AND THE EXTREMELY DIFFICULTY OF DISTAL STENT RECATHETERISATION, IT IS MOST LIKELY THE STENT WAS RENT BY THE DRAINAGE CATHETER. THIS IS NOT SURPRISING GIVEN THE BILIARY WALL'S ABILITY TO STRETCH AND NOT SUPPORT SUPERIOR STENT. WHEN THE DRAINAGE CATHETER ENCOUNTERED FRICTION IN THE NARROW AND TORTUOUS SEGMENT, IT MUST HAVE BOWED INTO THE DILATED BILIARY CONFLUENCE WITH ENOUGH FORCE TO TEAR THROUGH THE STENT WALL. THIS WAS FURTHER AGGRAVATED BY THE EXTREMELY LIMITED GUIDE WIRE PURCHASE. ONLY A VERY SHORT LENGTH OF STIFF WIRE EXTENDED PAST THE BEND. RESTENTING THE SEGMENT WAS LIKELY TECHNICALLY FEASIBLE BUT ONLY AFTER A STIFF GUIDE WIRE HAD BEEN PLACED MUCH DEEPER AND THE NEW STENT REVEALED FROM A SHEATH RATHER THAN ADVANCED BARE THROUGH THE PRE-EXISTING STENT. BASED ON THE REVIEW OF THE IMAGES, IT IS MOST LIKELY THAT THE STENT WAS TORN DURING INSERTION OF THE DRAINAGE CATHETER. FROM THE INFO PROVIDED, THE FRACTURED STENT REMAINS IN THE PT. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE RISK WAS ASSESSED FOR THIS COMPLAINT AND THE RISK WAS DETERMINED TO BE RISK CATEGORY LOW. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR ANY POTENTIAL TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A ZILVER 635 SELF EXPANDING BILIARY STENT WAS DEPLOYED ON A PT. THE PHYSICIAN THEN INSERTED A DRAINAGE CATHETER INSIDE THE STENT. THE ZILVER STENT TORE. THE PHYSICIAN TRIED TO IMPLANT A SECOND STENT TO CONSOLIDATE THE FIRST ONE BUT WAS NOT SUCCESSFUL SO THE SECOND STENT WAS NOT DEPLOYED NOR IMPLANTED. THE PHYSICIAN STATED THAT THE CASE WAS VERY DIFFICULT AND THE PT'S ANATOMY WAS NOT EASY. THE FRACTURED STENT REMAINS INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350711 ZILVER 635 SELF EXPANDING BILIARY STENT CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C967907

    Patients

    Seq Age Sex Outcome Treatment
    1