MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABIL® BILIARY ENDOPROSTHESIS (SW); CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	VSWVH1010
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was requested, however only the gender was reported.
Event or Problem Description
It was reported to gore by conmed (cen 5111) that a gore® viabil® biliary endoprosthesis was implanted in a patient during an ercp procedure.It was reported the device migrated eight weeks later.It was reported the stent moved up into the duct and was no longer transpapillary.Additionally, it was reported the patient was seen on (b)(6) 2019 for stent management when it was observed the stent had migrated approximately 5-7 millimeters proximally.
Additional Manufacturer Narrative
A2: patient age was reported.It was reported that it is unknown whether the stricture had previously been treated.It was further reported the device migrated proximally, about 1.5cm into the bile duct.Per the viabil instructions for use: hazards and adverse events complications associated with the use of the gore® viabil® biliary endoprosthesis may include complications associated with other biliary endoprostheses, including but not limited to: endoprosthesis misplacement, endoprosthesis migration, endoprosthesis fracture, obstruction of branch ducts, bleeding due to vascular erosion, and endoprosthesis occlusion due to biofilm/sludge formation, extrinsic compression or tumor overgrowth at the endoprosthesis ends.

• Brand Name: GORE VIABIL® BILIARY ENDOPROSTHESIS (SW)
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8853609
• Report Number: 3003910212-2019-00216
• Device Sequence Number: 11153430
• Product Code: FGE
• UDI-Device Identifier: 00733132638819
• UDI-Public: 00733132638819
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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?: No
• Operator of Device: No Information
• Device Expiration Date: 09/17/2021
• Device Catalogue Number: VSWVH1010
• Device Lot Number: 18598083
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR