MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	VSWVH1006
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Biliary Cirrhosis (1736)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation of device.
Event or Problem Description
It was reported to gore by conmed ((b)(4)) that during an ercp (endoscopic retrograde cholangiopancreatography).The gore¿ viabil¿ biliary endoprosthesis distal 4 cm, unraveled on removal.Reportedly the remaining proximal 2 cm stent is embedded into the tissue and was not able to be removed.It was reported that the proximal 2 cm of stent remains in the duct.Reportedly there was a 7 hour delay in the procedure.Reportedly a plastic stent was placed to keep the duct patent.It was reported that a removal procedure was scheduled for (b)(6) 2021.Reportedly the patient went home.
Additional Manufacturer Narrative
H6: it should be noted that the gore® viabil® biliary endoprosthesis instructions for use addresses the following: "this product is not intended for removability, and is considered a permanent implant".
Additional Manufacturer Narrative
Updated h6: removed code 24 (d1103) replaced with code d1101.

• Brand Name: GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12357120
• Report Number: 3003910212-2021-01281
• Device Sequence Number: 17102456
• Product Code: FGE
• UDI-Device Identifier: 00733132638796
• UDI-Public: 00733132638796
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K170740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2023

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: Health Professional
• Device Expiration Date: 04/06/2023
• Device Model Number: VSWVH1006
• Device Catalogue Number: VSWVH1006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 07/27/2021; 07/27/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 08/01/2022; 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown