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

Model Number	G25731
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional concomitant medical products: cook tracer hybrid wire guide.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the device, the gray distal tip of the device was not returned for evaluation along with the bands that are on the pushing catheter.The pushing catheter is glued to the inner catheter of the delivery system near the distal end of the device.The user stated that about 15 cm of the distal tip detached and was left in the patient to pass.There are two black bands on the pushing catheter, one on each side of the outer sheath, which were not returned.An inner sheath runs through the outer sheath of the pushing catheter that is a golden color.The two blacks bands are glued to the inner sheath and the outer sheath is placed between the two black bands.The outer sheath of the pushing catheter was returned and measured at 18 cm which was within tolerance.On one end of the outer sheath of the pushing catheter the end is damaged.The inner sheath that fits through the outer sheath was damaged and appears to have a section of it missing.The length of the inner sheath is 13.6 cm which is shorter than the tolerance of the entire length of the pushing catheter.The outer catheter of the zilver expandable metal biliary stent system device was measured at 207.7 cm which meets the minimum specification.An evaluation of the inner catheter was performed.The inner catheter was taken out of the device and was measured at 204.5 cm and is shorter than the tolerance, however kinks and bends were noted which could be preventing the device from meeting the specified length requirement during evaluation.The distal tip of the tubing was visually inspected under magnification and glue residue was present.There was evidence at the distal tip of the tubing that the tubing has been tapped (roughened for glue adhesion).The distance of the tapped area meets the requirement for the tapped length.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: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to the condition of the returned product and a variety of clinical conditions such as patient anatomy or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The user indicated the stent was placed in an angulated stricture and there was a tight waist on the stent after deployment.The tip of the stent deployment system was caught within the stent.It is likely the excess pressure placed on the device while trying to remove the tip is what caused the deployment system to break.To prevent the occurrence of the stent catching on the stent the instructions for use (ifu) includes the following "note: it is recommended to re-advance the outer sheath to its pre-deployment position prior to removing the system".Advancing the outer sheath will cover the proximal edges of the tip and reduce the likelihood it will catch on the inside of 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.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook zilver expandable metal biliary stent system.As reported to customer relations: ¿the patient had metastatic colon cancer and a biliary stricture at the hilum of the liver into the left intra hepatic ducts.The physician was using an (b)(4) ercp endoscope 180 and used a.021 [inch wire guide] to do a sphincterotomy and gain access into the bile duct.A cook tri-ex extraction balloon and a cook tracer hybrid wire guide (angled) was used to gain access into the left system.A tight stricture was seen which was angulated and a zilver expandable metal biliary stent system was placed over the guide wire and successfully deployed.There was a tight waist on the stent after deployment.The difficulty occurred when trying to remove the delivery system.The tip of the introducer got caught in the stent where it is narrow and takes a turn.The physician pulled harder and the introducer broke, leaving about 15 cm in the patient with the tip still connected.The patient is going to hospice; no intervention will be performed.".

• Brand Name: ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM
• Common Device Name: FGE, CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6896865
• Report Number: 1037905-2017-00612
• Device Sequence Number: 10967610
• Product Code: FGE
• UDI-Device Identifier: 10827002257310
• UDI-Public: (01)10827002257310(17)200525(10)W3866461
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K020788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2017

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 Model Number: G25731
• Device Catalogue Number: ZILBS-10-8
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2017
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2017
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1