MAUDE Adverse Event Report: COOK ENDOSCOPY ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM; FGE, BILIARY CATHETER AND ACCESSORIES

Model Number	G25731
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: olympus visiglide straight wire guide, unknown model.Grasper, unknown make or model.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A piece of the metal stent, measuring approximately 1.6 cm in length, was returned in a plastic medical bottle.On the portion of the metal stent that was returned, the four (4) golden rivets were observed as intact.The stent introduction and deployment system was not included in the return.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the root cause is use error.The information provided by the user indicated that the user placed the stent too far down and then repositioned the stent, which resulted in fracturing of the stent.The instructions for use warns, "warning: these metal biliary stents are not intended to be repositioned or removed after deployment in the bile duct.In case of accidental deployment or improper placement (immediately following deployment), stent should be left in place and placement of a second stent should be attempted achieve desired result." the user stated that there was resistance encountered when advancing the wire guide through the obstructed area.The instructions for use states, "precaution: if the wire guide or stent cannot advance through the obstructed area, do not attempt to place the stent." prior to distribution, all zilver expandable metal biliary stent systems are subjected to a visual and functional 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 action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.Additional comments regarding this report: based on the information provided that the metal stent was placed despite encountering resistance with wire guide placement and the metal stent was attempted to be repositioned, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Event or Problem Description
During a metal stent placement procedure, the physician used a cook zilver expandable metal biliary stent system.The stent was initially placed too far down.On the attempt to reposition the zilver stent [use error], part of it tore off.The other part remained in the patient.The following action was to place [another, new] stent in [the existing partial] stent.A portion of the originally deployed stent remained inside the patient¿s body as intended.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM
• Common Device Name: FGE, BILIARY CATHETER AND ACCESSORIES
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8068675
• Report Number: 1037905-2018-00521
• Device Sequence Number: 1593890
• Product Code: FGE
• UDI-Device Identifier: 10827002257310
• UDI-Public: (01)10827002257310(17)210315(10)W4038230
• Combination Product (Y/N): N
• PMA/510(K) Number: K020788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2021
• Device Model Number: G25731
• Device Catalogue Number: ZILBS-10-8
• Device Lot Number: W4038230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1