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

Device Problem Complete Blockage (1094)

Patient Problem Blood Loss (2597)

Event Date 06/01/2019

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.All information has been placed on file for use in tracking and trending.

Event Description

The following was presented at 48th annual meeting of the japanese society of interventional radiology, which was held in japan, on june 1, 2019.The abstract identified 8 cases that were treated for iatrogenic vascular injury using viabahn stent-grafting between (b)(6) 2017 and (b)(6) 2018 using the gore® viabahn® endoprosthesis.The abstract reported that with 1 of the cases implanted in the hepatic artery, anticoagulant therapy was performed after the procedure.However, thrombus occlusion was identified by computed tomography scan (ct) on the next day.

Manufacturer Narrative

Corrected data: g5 - combination product.

Manufacturer Narrative

Additional manufacturer narrative: b3 - date of event.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9227189
• MDR Text Key: 163586203
• Report Number: 2017233-2019-01084
• 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: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other