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

Catalog Number JHJR061002J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be performed as no lot number information was provided.The device(s) was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.Note: article publish date was 04/2019.No actual event date was provided.Therefore, date of event is an estimate based on article publish date.

Event Description

The following publication was reviewed: "a case of pseudoaneurysm due to chronic pancreatitis treated by viabahn".A 6x10 gore® viabahn® endoprosthesis with heparin bioactive surface was then advanced from the right hepatic artery to the common hepatic artery and deployed.Next, a 7x10 gore® viabahn® endoprosthesis with heparin bioactive surface was inserted to the common hepatic artery and deployed.Final angiography confirmed that the aneurysm was excluded.However, during the procedure, thrombus formation was observed in the right hepatic artery, therefore arterial injection (heparin and urokinase) was performed.The procedure was then completed.Currently there is no aneurysm present and the course of pancreatitis is good.

Manufacturer Narrative

Additional received information determined that this event is not reportable to the fda and therefore the medwatch (and supplementals) will be retracted.

Manufacturer Narrative

Corrected data: h6.Conclusions code 1.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9350888
• MDR Text Key: 167576092
• Report Number: 2017233-2019-01166
• 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,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR061002J
• 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: 61 YR