MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problem Compatibility Problem (2960)

Patient Problems Occlusion (1984); Perforation (2001)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

The item number and lot number of the device could not be provided, so no manufacturing evaluation could not be performed.The device remains implanted.Therefore, direct product analysis was not possible.

Event Description

The following publication was reviewed: "management of extracranial carotid artery aneurysms: a 6-year case series" received through "med sci monit, 2019; 25: 4933-4940".The authors: zuoguan chen, lidan chen, et al.The article aimed to discuss the presentation and management of extracranial carotid artery aneurysms (ecaas) and to develop a new type of classification.A retrospective review of 35 ecaas patients who were admitted in our institution from january 2010 to june 2016 was conducted.The mean follow-up period was 25.58±22.13 months.The results stated only 1 patient experienced stent-graft stenosis(viabahn (6¿50 mm)) at 11 months after treatment (endovascular therapy).Balloon dilation and stent grafting were used to achieve a second patency.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10458337
• MDR Text Key: 204596720
• Report Number: 2017233-2020-01185
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 08/27/2020
• 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): Required Intervention
• Patient Age: 51 YR