MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number JHJR050502J

Device Problem Complete Blockage (1094)

Patient Problem Pseudoaneurysm (2605)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be performed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.No actual event date was provided.Therefore, date of event is an estimate based on publication date of the article.Refer to medwatch #2017233-2019-00230 for other device.

Event Description

The following publication was reviewed: gore viabahn stentgraft for injured artery; clinical imagiology; volume 35, number 2, page 219-223 (published in february 2019).The article includes the following case: case 2 was a male whose age was in his seventies.The patient previously underwent left hepatic trisegmentectomy for hilar cholangiocarcinoma.On an unknown date, pseudosneurysms at the right hepatic artery and the origin of the gastroduodenal artery were confirmed.Two gore® viabahn® endoprosthesis with heparin bioactive surface were implanted to cover the pseudoaneurysm in both arteries.The pseudoaneursyms were successfully excluded.Seven days after the initial procedure, computed tomography angiography showed that the endoprosthesis in the right hepatic artery was occluded.Abscess formation around the endoprosthesis was also observed.On the same day, angiography showed that both endoprostheses were occluded.Distal portion of the right hepatic artery had blood flow through a collateral vessel from the right inferior phrenic artery which occurred at the right renal artery.There was no hepatic dysfunction.

Manufacturer Narrative

Other relevant history, including preexisting medical conditions.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8519540
• MDR Text Key: 142119099
• Report Number: 2017233-2019-00229
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR050502J
• 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