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

Catalog Number	PTB8108275
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	12/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient weight or date of birth were not available.The imaging evaluation was able to confirm the physician¿s event description that balloon thrombectomy was being performed.No images were provided of the device after it had been dislodged to the right atrium, so the distance that the device was dislodged was unable to be confirmed.
Event or Problem Description
It was reported the physician deployed a gore® viatorr® tips endoprosthesis.The patient had preexisting portal vein thrombosis.One day later, the physician was performing a balloon thrombectomy.During one of the passes, the viatorr® device was dislodged to the right atrium.The physician was able to pull the expanded device out through the internal jugular, which enlarged the access site.A 16 fr sheath with a suture around it was used to achieve hemostasis.A vascular surgeon closed the access site once the procedure was finished.The patient was doing well following the procedure.
Additional Manufacturer Narrative
Updated conclusion code.

• Brand Name: GORE VIATORR TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION
• Common Device Name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8489480
• Report Number: 3007284313-2019-00098
• Device Sequence Number: 1921981
• Product Code: MIR
• UDI-Device Identifier: 00733132635047
• UDI-Public: 00733132635047
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: Health Professional
• Device Expiration Date: 09/09/2021
• Device Catalogue Number: PTB8108275
• Device Lot Number: 18570143
• 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: 04/05/2019
• Supplement Report FDA Received Date: 04/25/2019
• 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: Other
• Patient Age: 39 YR