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

Catalog Number	ZILBS-10-8
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	06/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: olympus clever cut papillotome, boston scientific.035 jag wire.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.Only a partial section of the metal stent was returned for evaluation.A visual evaluation was performed on the stent.It appears from the side of the stent that is still intact that the damage of the stent begins at 2.2 cm from the intact side.The stent is stretched and mangled for 2.7 cm.The length of the stent fully intact would be 8 cm.Around 6 cm of the stent is missing.All four gold rivets are still in place on the side of the stent that is still intact.The rest of the device could not be evaluated because it was not returned.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 the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The instructions for use state: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." the instructions for use precautions: "if the wire guide or stent cannot advance through the obstructed area, do not attempt to place the stent." the instructions for use warns: "this device is not intended to be deployed through the wall of a previously placed or existing metal stent.Doing so could result in difficulty or inability to remove introducer." the instructions for use warns: "this stent is not intended to be removed.Attempts to remove the stent after placement may cause damage to the surrounding mucosa.This stent is considered to be a permanent implant." the instructions for use warns: "do not push delivery system up into bile duct after stent deployment has been initiated." prior to distribution, all zilver expandable metal biliary stent system 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 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 procedure the physician used a cook zilver expandable metal biliary stent system.The zilver expandable metal biliary stent was deployed successfully in the targeted zone.When the physician went to remove the delivery system and wire guide, a portion of the proximal end strut was fractured and came out of the bile duct.The fractured portion was retrieved leaving the remaining stent in the correct position.

• 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: 5782532
• Report Number: 1037905-2016-00242
• Device Sequence Number: 13612850
• Product Code: FGE
• UDI-Device Identifier: 10827002257310
• UDI-Public: (01)10827002257310(17)161001(10)W3337178
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K040930
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/16/2016

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ZILBS-10-8
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/16/2016
• Device Age: 3 YR
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2016
• Initial Report FDA Received Date: 07/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS 180 ERCP ENDOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention