BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    MDR report key: 5520371 · Received March 23, 2016

    Report

    Report Number
    3001845648-2016-00072
    Event Type
    Injury
    Date Received
    March 23, 2016
    Date of Event
    February 19, 2016
    Report Date
    March 22, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002438238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P050017/S002 AND S003. THE 1 X ZIV6-35-125-6-80 DEVICE OF LOT NUMBER C1175291 WAS RETURNED FOR EVALUATION. DEVICE WAS NOT RETURNED IN THE ORIGINAL PACKAGING AND WAS OPEN ON RECEIPT. ON EVALUATION OF THE RETURNED DEVICE IT WAS EVIDENT THAT THE STENT WAS DEPLOYED DURING THE PROCEDURE AND THE INNER PEEK TUBING WAS EXPOSED ON RETURN. ON VISUAL EXAMINATION OF THE EXPOSED INNER PEEK TUBING, IT WAS NOTED THAT THE UV GLUE HAD COME APART FROM THE PROXIMAL END OF THE WHITE TIP. NO OTHER DAMAGE WAS NOTED TO THE INNER PEEK TUBING. THE OUTER SHEATH HAS BEEN EXAMINED FOR DAMAGE AND NO OTHER DAMAGE WAS NOTED. USING CALIBRATED RULER THE OUTER SHEATH MEASURED 125.4 CM AND WAS NOTED TO BE AS PER SPECIFICATION. THE WHITE TIP WAS CHECKED FOR DAMAGE, NO DAMAGE WAS NOTED. THE CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED. UPON EXAMINATION OF THE RETURNED DEVICE, THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS MANUFACTURED INCORRECTLY. THE BELOW LIST INDICATES POTENTIAL RISK FACTORS THAT CAN GENERALLY CONTRIBUTE TO A THROMBOSIS EVENT: PATIENT FACTORS: HISTORY OF COAGULOPATHY/PRIOR THROMBOSIS (E.G., DVT), DIABETES, ESPECIALLY IF POORLY CONTROLLED, CANCER/CHEMOTHERAPY, ADVANCED AGE, OBESITY, HYPERLIPIDEMIA, HYPERTENSION, SMOKING. LESION FACTORS: LONG LESION, SMALL VESSEL DIAMETER, SEVERE CALCIFICATION, LESION TOTALLY OCCLUDED PRIOR TO STENT PLACEMENT, PLACEMENT FOR IN STENT RESTENOSIS. PROCEDURE FACTORS: RESIDUAL INFLOW, OUTFLOW, OR IN-SEGMENT STENOSIS OR DISSECTION, POOR RUN OFF (I.E., BEYOND TRIFURCATION), MEDICATION FACTORS, INADEQUATE PROCEDURAL HEPARINIZATION, INADEQUATE LOADING DOSE OF ANTIPLATELET (TICLOPIDINE OR CLOPIDOGREL), INADEQUATE DAPT PRESCRIBED, NON-RESPONDER TO THE APT, OR NON-COMPLIANT WITH PRESCRIBE REGIMEN. IT IS UNKNOWN AT THIS TIME IF THE PATIENT EXPERIENCED ANY OF THE KNOWN POTENTIAL RISK FACTORS THAT CAN CONTRIBUTE TO A THROMBOSIS EVENT. THIS INFORMATION HAS BEEN REQUESTED AND THIS FILE WILL BE UPDATED FOLLOWING RECEIPT OF INFORMATION. AS IMAGING IS CURRENTLY UNAVAILABLE FOR THIS COMPLAINT FILE, AND THERE IS NO EVIDENCE TO SUGGEST THAT THROMBUS DID NOT OCCUR, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. PRIOR TO DISTRIBUTION ALL ZIV6-35-125-6-80 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. ACCORDING TO THE INITIAL REPORTER, THE COMPLAINT DEVICE WAS IMPLANTED IN THE PATIENT AS INTENDED. HOWEVER THE NEXT DAY THE PATIENT EXPERIENCED STENT THROMBOSIS AND UNDERWENT A FEM/POP BYPASS. FURTHER INFORMATION HAS BEEN REQUESTED REGARDING PATIENT OUTCOME. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P050017/S002 AND S003. ONE (1) X ZIV6-35-125-6-80 DEVICE OF LOT NUMBER C1175291 WAS RETURNED FOR EVALUATION. DEVICE WAS NOT RETURNED IN THE ORIGINAL PACKAGING AND WAS OPEN ON RECEIPT. ON EVALUATION OF THE RETURNED DEVICE IT WAS EVIDENT THAT THE STENT WAS DEPLOYED DURING THE PROCEDURE AND THE INNER PEEK TUBING WAS EXPOSED ON RETURN. ON VISUAL EXAMINATION OF THE EXPOSED INNER PEEK TUBING, IT WAS NOTED THAT THE UV GLUE HAD COME APART FROM THE PROXIMAL END OF THE WHITE TIP. NO OTHER DAMAGE WAS NOTED TO THE INNER PEEK TUBING. THE COMPLAINT INFORMATION ALONG WITH THE LAB EVALUATION DETAILS WERE FORWARDED TO R&D ENGINEER FOR REVIEW. THE FOLLOWING COMMENTS WERE PROVIDED WITH REGARD TO THE UV GLUE SEPARATING FROM THE PROXIMAL END OF THE WHITE TIP: ¿THE USER HAD DIFFICULTIES DEPLOYING THE STENT. THIS WOULD HAVE LED TO THE SHEATH BEING STRETCHED AND RELAXED POTENTIALLY SEVERAL TIMES. THIS MAY HAVE LED TO THE STENT RIDING UP ON THE UV. I NOTICED IN ONE IMAGE SOME INDENTS ON THE UV FILLET POTENTIALLY FROM THE EYELETS AT THE DISTAL END OF THE STENT. THIS INTERACTION OF THE STENT WITH THE UV GLUE COULD HAVE PULLED THE FILLET AWAY FROM THE PROXIMAL EDGE OF THE TIP¿. R&D ENGINEERING HAS CONFIRMED THAT SEPARATION OF THE UV GLUE FROM THE WHITE TIP 'IS UNLIKELY TO HAVE CAUSED OR CONTRIBUTED TO THE ¿DEPLOYMENT DIFFICULTIES¿ THE PHYSICIAN EXPERIENCED. THE UV GLUE SEPARATION IS AN OUTCOME/EFFECT OF THE DEPLOYMENT DIFFICULTIES'. THE OUTER SHEATH HAS BEEN EXAMINED FOR DAMAGE AND NO OTHER DAMAGE WAS NOTED. USING CALIBRATED RULER THE OUTER SHEATH MEASURED 125.4 CM AND WAS NOTED TO BE AS PER SPECIFICATION. THE WHITE TIP WAS CHECKED FOR DAMAGE, NO DAMAGE WAS NOTED. THE CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED. UPON EXAMINATION OF THE RETURNED DEVICE, THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS MANUFACTURED INCORRECTLY. NO DEFECTS WERE OBSERVED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE DEPLOYMENT DIFFICULTIES THE PHYSICIAN EXPERIENCED DURING THE PROCEDURE. AS THERE IS NO EVIDENCE TO SUGGEST THAT DEPLOYMENT DIFFICULTY DID NOT OCCUR, THE DEPLOYMENT DIFFICULTY IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO ADDITIONAL INFORMATION RECEIVED FOR THIS FILE, THE USER IS EXPERIENCED IN USING THE ZIV6-35-125-6-80 DEVICE. IT IS UNKNOWN IF THE TARGET SITE WAS SEVERELY CALCIFIED. IT IS KNOWN THAT AN AMPLANTZ 0.035 INCH WIRE GUIDE WAS USED DURING THIS PROCEDURE. PRE DILATATION WAS CONDUCTED BEFORE STENT DEPLOYMENT. WHEN THE USER EXPERIENCED DEPLOYMENT DIFFICULTIES THE PHYSICIAN STOPPED DEPLOYMENT AND ELASTIC RECOIL OCCURRED ON THE RETRACTION SHEATH. THE USER CONFIRMED RESISTANCE ON WITHDRAWING THE DEVICE FROM THE PATIENT. IT IS UNKNOWN IF THE THROMBOSIS OCCURRED AS A RESULT OF DEPLOYMENT DIFFICULTIES THE PHYSICIAN EXPERIENCED OR IF THERE WERE ANY RISK FACTORS FOR STENT THROMBOSIS. IMAGING/VIDEO OF THE PROCEDURE IS UNAVAILABLE FOR THIS FILE. IT WAS REPORTED THAT THE PATIENT IS NOW IN A STABLE CONDITION. THE USER ANSWERED ¿NO¿ TO THE FOLLOWING QUESTIONS: WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE THROUGH THE OBSTRUCTED AREA? WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE STENT AND INTRODUCER THROUGH THE OBSTRUCTED AREA? THE BELOW LIST INDICATES POTENTIAL RISK FACTORS THAT CAN GENERALLY CONTRIBUTE TO A THROMBOSIS EVENT: PATIENT FACTORS: HISTORY OF COAGULOPATHY/PRIOR THROMBOSIS (E.G., DVT). DIABETES, ESPECIALLY IF POORLY CONTROLLED. CANCER/CHEMOTHERAPY. ADVANCED AGE. OBESITY, HYPERLIPIDEMIA, HYPERTENSION. SMOKING. LESION FACTORS. LONG LESION, SMALL VESSEL DIAMETER, SEVERE CALCIFICATION. LESION TOTALLY OCCLUDED PRIOR TO STENT PLACEMENT. PLACEMENT FOR IN STENT RESTENOSIS. PROCEDURE FACTORS: RESIDUAL INFLOW, OUTFLOW, OR IN-SEGMENT STENOSIS OR DISSECTION. POOR RUN OFF (I.E., BEYOND TRIFURCATION). MEDICATION FACTORS: INADEQUATE PROCEDURAL HEPARINIZATION. INADEQUATE LOADING DOSE OF ANTIPLATELET (TICLOPIDINE OR CLOPIDOGREL). INADEQUATE DAPT PRESCRIBED. NON-RESPONDER TO THE APT, OR NON-COMPLIANT WITH PRESCRIBE REGIMEN. IT IS UNKNOWN AT THIS TIME IF THE PATIENT EXPERIENCED ANY OF THE KNOWN POTENTIAL RISK FACTORS THAT CAN CONTRIBUTE TO A THROMBOSIS EVENT. AS IMAGING IS UNAVAILABLE FOR THIS COMPLAINT FILE, AND THERE IS NO EVIDENCE TO SUGGEST THAT THROMBUS DID NOT OCCUR, THROMBOSIS IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO INPUT FROM R&D ENGINEER: ¿THROMBOSIS IS A RISK ANY TIME A FOREIGN BODY IS LEFT IN A BLOOD VESSEL AND THIS COMPLICATION CAN OCCUR WITH THE ZILVER PTX STENT, BARE METAL VASCULAR STENTS AND SYNTHETIC BYPASS GRAFTS. CLINICAL INPUT IS REQUIRED HERE TO DETERMINE IF THE DIFFICULTY DEPLOYING THE STENT IS SPECIFICALLY LINKED TO STENT THROMBOSIS¿. AVAILABLE INFORMATION WAS FORWARDED FOR CLINICAL INPUT; THE MEDICAL SCIENCE OFFICER PROVIDED THE FOLLOWING COMMENTS: ¿BASED ON THAT LIMITED INFORMATION, IT¿S HARD TO SAY EXACTLY WHAT HAPPENED DURING THE DEPLOYMENT THAT MAY/MAY NOT HAVE CONTRIBUTED TO THROMBUS FORMATION. THE DESCRIPTION BELOW (¿KEPT THE PIN AND PULL FOR A COUPLE SECONDS¿) SOUNDS INNOCUOUS, BUT THEN IT ALSO SAYS THE STENT ¿FINALLY¿ DEPLOYED, WHICH SUGGESTS THERE WAS MORE GOING ON THAN JUST HOLDING THE PIN AND PULL FOR A COUPLE SECONDS. FOR EXAMPLE, I¿M WONDERING WHETHER THERE WERE ADDITIONAL MANIPULATIONS DURING THIS DIFFICULT DEPLOYMENT THAT MAY HAVE RESULTED IN SOME LOCAL INTIMAL DAMAGE THAT COULD HAVE CONTRIBUTED TO THROMBUS FORMATION¿. THE USER WAS QUERIED REGARDING IF ADDITIONAL MANIPULATIONS WERE REQUIRED DURING THIS PROCEDURE. THE USER PROVIDED THE FOLLOWING COMMENTS "DR SAID I DONT KNOW. COULD BE OR COULD NOT." BASED ON THE ABOVE, THE CAUSE OF THE DEPLOYMENT DIFFICULTIES THE PHYSICIAN EXPERIENCED IS UNKNOWN. IT IS POSSIBLE THAT THE DEPLOYMENT DIFFICULTIES THE PHYSICIAN EXPERIENCED MAY HAVE RESULTED IN LOCAL INTIMAL DAMAGE THAT COULD HAVE CONTRIBUTED TO THROMBUS. HOWEVER, IN THIS CASE THIS HAS NOT BEEN CONFIRMED. IT IS HIGHLY UNLIKELY THAT THIS COMPLAINT EVENT OCCURRED AS A RESULT OF ZILVER BMS MALFUNCTION, HOWEVER DUE TO LACK OF IMAGING A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. IN ADDITION IT CAN BE NOTED THAT THE SEPARATION OF THE UV GLUE FROM THE WHITE TIP HAS BEEN CONCLUDED AS AN OUTCOME/EFFECT OF THE DEPLOYMENT DIFFICULTIES AND IS UNLIKELY TO HAVE CAUSED OR CONTRIBUTED TO THE DEPLOYMENT DIFFICULTIES AS DESCRIBED. THE COMPLAINT IS CONFIRMED AS DEPLOYMENT DIFFICULTY. PRIOR TO DISTRIBUTION ALL ZIV6-35-125-6-80 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE CAUSE OF THE DEPLOYMENT DIFFICULTIES THE PHYSICIAN EXPERIENCED IS UNKNOWN. IT IS POSSIBLE THAT THE DEPLOYMENT DIFFICULTIES THE PHYSICIAN EXPERIENCED MAY HAVE RESULTED IN LOCAL INTIMAL DAMAGE THAT COULD HAVE CONTRIBUTED TO THROMBUS. HOWEVER THIS HAS NOT BEEN CONFIRMED BY THE USER. IT IS HIGHLY UNLIKELY THAT THIS COMPLAINT EVENT OCCURRED AS A RESULT OF ZILVER BMS MALFUNCTION, HOWEVER DUE TO LACK OF IMAGING A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. ACCORDING TO THE INITIAL REPORTER, THE COMPLAINT DEVICE WAS IMPLANTED IN THE PATIENT AS INTENDED. HOWEVER THE NEXT DAY THE PATIENT EXPERIENCED STENT THROMBOSIS AND UNDERWENT A FEM/POP BYPASS. ACCORDING TO ADDITIONAL INFORMATION RECEIVED FOR THIS FILE, IT IS KNOWN THAT THE PATIENT IS IN A STABLE CONDITION. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    USER COULD NOT FULLY DEPLOY THE ZILVER STENT. THE USER PREVIOUSLY FLUSHED BOTH LUMENS ON THE STENT SYSTEM. THE STENT WAS UNSHEATHED PARTIALLY AND THE DOCTOR DID THE PIN AND PULL. USER KEPT DOING THE PIN AND PULL (FOR A COUPLE OF SECONDS) AND FINALLY THE STENT DEPLOYED. NEXT DAY THE PATIENT HAD A STENT THROMBOSIS AND UNDERWENT A FEM/POP BYPASS.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF ADDITIONAL INFORMATION WHICH IMPACTS THE INVESTIGATION CONCLUSIONS. NOTE THE UPDATE TO THE INVESTIGATION OF THIS EVENT CONCLUDED THE DEPLOYMENT DIFFICULTIES EXPERIENCED BY THE USER WERE PROCEDURAL RELATED AND NOT DEVICE RELATED. THIS EVENT HAS BEEN RE-CATEGORIZED AS A SERIOUS INJURY/ADVERSE EVENT REPORT. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: USER COULD NOT FULLY DEPLOY THE ZILVER STENT. THE USER PREVIOUSLY FLUSHED BOTH LUMENS ON THE STENT SYSTEM. THE STENT WAS UNSHEATHED PARTIALLY AND THE DOCTOR DID THE PIN AND PULL. USER KEPT DOING THE PIN AND PULL (FOR A COUPLE OF SECONDS) AND FINALLY THE STENT DEPLOYED. NEXT DAY THE PATIENT HAD A STENT THROMBOSIS AND UNDERWENT A FEM/POP BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175197 ZILVER 635 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD 10827002438238

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention