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

Catalog Number PTB8108275

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Skin Tears (2516)

Event Date 12/15/2018

Event Type  Injury  

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 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.

Manufacturer Narrative

Updated conclusion code.

• Brand Name: GORE VIATORR TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8489480
• MDR Text Key: 141168188
• Report Number: 3007284313-2019-00098
• Device Sequence Number: 1
• Product Code: MIR
• UDI-Device Identifier: 00733132635047
• UDI-Public: 00733132635047
• Combination Product (y/n): N
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR