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

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be completed 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.Note: this event was originally reported to fda in medwatch #2017233-2019-00481 & #2017233-2019-00483.This report addresses the pseudoaneurysm, occlusion, and additional surgical procedure of the same event.

Event Description

The following was reported to gore: on an unknown date, a biliary metallic stent (mfg unknown) was placed to treat unresectable pancreatic head cancer.The patient also received chemotherapy at that time.After treatment, the patient vomited blood frequently.Pseudoaneurysm in the proximal part of superior mesenteric artery associated with infection was observed by the doctor.To treat the pseudoaneurysm, a gore® viabahn® endoprostheses was placed and dual antiplatelet therapy (dapt) was performed.On an unknown date, a new pseudoaneurysm was observed in the distal part of the gore® viabahn® endoprostheses.A second gore® viabahn® endoprostheses was placed at that time.During placement, acute occlusion of the first gore® viabahn® endoprostheses occurred.To resolve the occlusion, thrombectomy was performed.It was confirmed that the superior mesenteric artery was patent and no ischemia was detected.

Manufacturer Narrative

Additional manufacturer narrative: g5 - combination product, g5 - pre-1938, g5 - otc product.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8918612
• MDR Text Key: 155186826
• Report Number: 2017233-2019-00699
• 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
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/24/2019; 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention