MAUDE Adverse Event Report: COOK ENDOSCOPY ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM; FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	G25730
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter occupation: unknown.Investigation evaluation: the customer provided four images.Two of the pictures are imaging done on the patient, showing the tip of the device inside the patient.The other two images show the distal end of the device, where the pushing catheter and catheter tip are missing.The report is considered confirmed solely based on pictures provided by the customer.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Prior to distribution, all silver 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 re-assess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a silver expandable metal biliary stent system.The user deployed the stent without an issue.The tip of the inner sheath detached and remained in the patient.One part of the broken tip is in the hilar bile duct and the other part is in the patient's stomach.A section of the device detached initially, but ultimately did not remain inside the patient¿s body.The detached inner sheath was retrieved 4 days after the procedure due to this occurrence during another endoscopic procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: the customer provided four images.Two (2) of the pictures are imaging done on the patient, showing the tip of the device inside the patient.The other two images show the distal end of the device, where the pushing catheter and catheter tip are missing.Our laboratory evaluation of the product said to be involved confirmed the report as described.During a visual evaluation, the pushing catheter was detached from the inner catheter.The device was returned in two pieces.The pushing catheter was severely damaged throughout most of it's length, the damage possibly occurred during retrieval from the patient with forceps.There is a red substance on some parts of the pushing catheter.There were also kinks and bends throughout the length of the rest of the device.A meeting was held with manufacturing and production engineering, to further evaluate the device.The tubing that connects to the pushing catheter, was measured to verify tubing had been tapped.The tubing was cut open, and glue was visible in the threads.No anomalies were detected with the device construction.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.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The investigation confirmed the joint was manufactured correctly.The tubing and pushing catheter can pull apart if the device experiences excessive force during removal from the patient.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), the physician used a zilver expandable metal biliary stent system.The user deployed the stent without an issue.The tip of the inner sheath detached and remained in the patient.One part of the broken tip is in the hilar bile duct and the other part is in the patient's stomach.Additional information was received on 14-september-2020 which states that the user removed the remaining part of device by forceps under an additional endoscopic procedure.A section of the device detached initially, but ultimately did not remain inside the patient¿s body.The detached inner sheath was retrieved 4 days after the procedure due to this occurrence during another endoscopic procedure.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 STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10538002
• Report Number: 1037905-2020-00383
• Device Sequence Number: 3819239
• Product Code: FGE
• UDI-Device Identifier: 10827002257303
• UDI-Public: (01)10827002257303(17)220315(10)W4192042
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K020788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2022
• Device Model Number: G25730
• Device Catalogue Number: ZILBS-10-6
• Device Lot Number: W4192042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 08/23/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/13/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC YELLOW ZEBRA WIRE GUIDE; OLYMPUS ENDOSCOPE, 260
• Outcome Attributed to Adverse Event: Required Intervention