MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIATORR TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION; SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS

Model Number	PTB8107275
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® viatorr® tips endoprosthesis with controlled expansion instructions for use includes, but is not limited to the following potential device or procedure-related adverse events associated with the use of the device: device occlusion.
Event or Problem Description
It was reported the physician implanted a gore® viatorr® tips endoprosthesis with controlled expansion on (b)(6) 2021.On (b)(6) 2021 a likely occlusion of the device was noted.On (b)(6) 2021 a revision occured to clear an occlusion at the portal venous end of the stent, near the junction of the chain link and covered portion.An angiojet was used to de-clot, then the lesion was ballooned.The patient was doing well following the procedure.

• Brand Name: GORE VIATORR TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION
• Common Device Name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12554544
• Report Number: 3007284313-2021-01608
• Device Sequence Number: 17258277
• Product Code: MIR
• UDI-Device Identifier: 00733132635030
• UDI-Public: 00733132635030
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

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: 03/07/2024
• Device Model Number: PTB8107275
• Device Catalogue Number: PTB8107275
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/30/2021
• 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: 51 YR
• Patient Weight: 95