BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER BILIARY SELF-EXPANDING METAL STENT

    MDR report key: 1369797 · Received April 24, 2009

    Report

    Report Number
    1037905-2009-00073
    Event Type
    Injury
    Date Received
    April 24, 2009
    Date of Event
    March 26, 2009
    Report Date
    March 26, 2009
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FGE
    PMA / PMN Number
    K020788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED TO US BY OUR DISTRIBUTOR IN ANOTHER COUNTRY, ON BEHALF OF A MEDICAL FACILITY. THE MEDICAL FACILITY INVOLVED IN THIS REPORT IS LISTED. THE CONTACT DETAILS FOR OUR DISTRIBUTOR IN ANOTHER COUNTRY ARE: REGULATORY AFFAIRS COOK INC., EVALUATION: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVALUATION. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOOD INVENTORY. CONCLUSIONS: INFORMATION PROVIDED INDICATED THE STENT WAS PLACED FOR PALLIATION OF PANCREATIC CANCER. THE REPORT INDICATED RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE THROUGH THE STRICTURE AND WHEN ADVANCING THE INTRODUCER INTO POSITION. RESISTANCE DURING INTRODUCTION SYSTEM REMOVAL CAN OCCUR IF THE STENT IS PLACED IN A SEVERE STRICTURE. THIS IS THE MOST LIKELY CAUSE FOR THE REPORTED DIFFICULTY WITH INTRODUCTION SYSTEM REMOVAL AFTER STENT DEPLOYMENT. A CAUTION LOCATED IN THE DEVICE INSTRUCTIONS FOR USE ADVISES THE USER TO AVERT STENT PLACEMENT IF A WIRE GUIDE WILL NOT ADVANCE THROUGH THE STRICTURE. THE INFORMATION PROVIDED INDICATED A BILIARY DILATION WAS NOT COMPLETED PRIOR TO STENT DEPLOYMENT. IF THE STENT IS PLACED IN A SEVERELY TIGHT STRICTURE WITHOUT PRIOR DILATION, THIS COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION. THE INSTRUCTIONS FOR USE FOR THIS DEVICE CAUTION THE USER THAT ASSESSMENT MUST BE MADE TO DETERMINE THE NECESSITY OF BALLOON DILATION PRIOR TO STENT PLACEMENT. PRIOR TO DISTRIBUTION, ALL ZILVER BILIARY SELF-EXPANDING METAL STENTS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTIONS: A FORMAL PREVENTATIVE/CORRECTIVE ACTION HAS BEEN CONDUCTED IN RESPONSE TO THIS OBSERVATION. THE APPROPRIATE PERSONNEL IMPLEMENTED A PROCESS AND INSPECTION CHANGE IN 2009, TO REDUCE FUTURE OCCURRENCES OF THIS NATURE. THIS DEVICE WAS MANUFACTURED PRIOR TO THIS IMPLEMENTATION. PRIOR TO DISTRIBUTION, ALL ZILVER BILIARY SELF-EXPANDING METAL STENT ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ENDOSCOPY ZILVER BILIARY SELF-EXPANDING METAL STENT. THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN ADVANCING THE WIRE GUIDE AND THE INTRODUCTION SYSTEM INTO POSITION. THE STENT DEPLOYED WITHOUT DIFFICULTY. WHEN ATTEMPTING TO REMOVE THE INTRODUCTION SYSTEM FROM THE STENT, THE INTRODUCTION SYSTEM BECAME LODGED ON THE DEPLOYED STENT. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO PULL THE INTRODUCTION SYSTEM OUT OF THE BILE DUCT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE, THE HANDLE OF THE DEVICE WAS REMOVED. THE PATIENT WAS SENT TO SURGERY AND THE INTRODUCER WAS CUT AT THE BILE DUCT, LEAVING THE REMAINDER OF THE INTRODUCTION SYSTEM INSIDE THE DEPLOYED STENT. OTHER THAN SURGICAL REMOVAL OF A PORTION OF THE INTRODUCTION SYSTEM, NO FOREIGN OBJECT WAS RETRIEVED FROM THE PATIENT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZILVER BILIARY SELF-EXPANDING METAL STENT FGE, CATHETER, BILIARY, DIAGNOSTIC FGE COOK ENDOSCOPY W2591533

    Patients

    Seq Age Sex Outcome Treatment
    1 80+ Required Intervention