MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS; SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Device Problem Insufficient Information (3190)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/04/2020

Event Type  Injury  

Manufacturer Narrative

Due to an unknown lot/serial number and no device return, an investigation could not be performed.

Event Description

The following information was received through literature ¿contemporary outcomes of open and endovascular intervention for extracranial carotid artery aneurysms: a single centre experience¿ published by carotid and supra-aortic arteries, eur j vasc endovasc surg (2020) 60, 347-354.The study was to to evaluate the outcomes of open surgery (os) and endovascular surgery (es) for extracranial carotid aneurysm (ecca) in the authors¿ centre.Fifty-seven consecutive patients(35 patients underwent os, 20 patients underwent es and 2 patients underwent os after the failure of es) who were diagnosed with ecca and underwent intervention from january 2005 to july 2019 at zhongshan hospital, fudan university, were reviewed retrospectively.A covered stent was used most commonly in es (16/20 cases, 80.0%).The viabahn endoprosthesis (gore) was used in nine cases.The results state that one es carotid occlusions were found during a mean imaging follow up of 30 months.

Manufacturer Narrative

Literature citation: the article name: contemporary outcomes of open and endovascular intervention for extracranial carotid artery aneurysms: a single centre experience the authors: song xue, xiao tang, gefei zhao, hanfei tang, yang shen, ethan y.Yang, weiguo fu, zhenyu shi, daqiao guo.Department of vascular surgery, institute of vascular surgery, zhongshan hospital, fudan university, shanghai, china.2020 european society for vascular surgery.Published by elsevier b.V.All rights reserved.Eur j vasc endovasc surg (2020) 60, 347-354.Received (b)(6) 2019, accepted (b)(6) 2020, available online (b)(6) 2020.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12119643
• MDR Text Key: 262218448
• Report Number: 2017233-2021-02133
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR