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

Model Number PTB8107275

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/09/2021

Event Type  Injury  

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 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
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12554544
• MDR Text Key: 274037303
• Report Number: 3007284313-2021-01608
• Device Sequence Number: 1
• Product Code: MIR
• UDI-Device Identifier: 00733132635030
• UDI-Public: 00733132635030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2024
• Device Model Number: PTB8107275
• Device Catalogue Number: PTB8107275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 95