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

Catalog Number JHJR050502J

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Review of the manufacturing records verified that the lot met release requirements.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.See medwatch #2017233-2019-00186 for device # (b)(4).

Event Description

The following was reported to gore: on (b)(6) 2017, this patient underwent endovascular repair for iatrogenic hepatic artery injury using two gore® viabahn® endoprosthesis with heparin bioactive surface.The patient tolerated the procedure.On an unknown date (probably at least one year after the initial procedure), computed tomography was performed, however, the endoprostheses were not found in the artery.Imaging was performed from top to toe, and there were no endoprostheses found.The physician assumed that the hepatic artery adhered to and perforated the bowel, and the endoprostheses were discharged outside the body.This was only speculation but the physician considered very probable.It was reported that no clinical problem occurred.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8510742
• MDR Text Key: 145168429
• Report Number: 2017233-2019-00185
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2018
• Device Catalogue Number: JHJR050502J
• Device Lot Number: 14857800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other