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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thrombosis (2100)

Event Date 05/08/2012

Event Type  Injury  

Manufacturer Narrative

As it is unknown which device(s) may have contributed to the thrombosis, an additional gore® viabahn® endoprosthesis devices have been included in this report: (lot number unknown and udi unknown).

Event Description

The following literature article was reviewed: "overcoming challenges of endovascular treatment of complex subclavian and axillary artery injuries in hypotensive patients" ramyar gilani, md et at.Journal of trauma acute care surgery volume 73, number 3 submitted: february 21, 2012; revised: may 6, 2012; accepted: may 8, 2012.Method: from (b)(6) 2010, to (b)(6) 2011, patients who presented to (b)(6)hospital in (b)(6) with subclavian or axillary artery injuries were taken to a trauma operating room equipped with a mobile c-arm and fluoroscopic bed for attempted endovascular repair of their injuries.After repair, patients were followed up both clinically and by serial vascular ultrasound as surveillance.Patients were tracked prospectively through a vascular trauma database.Results: a total of eight consecutive patients with subclavian and axillary artery injuries underwent endovascular repair with the use of the previously described technique.There were no iatrogenic injuries represented in this patient group.The sample group includes all patients with subclavian and axillary injuries that presented to (b)(6) hospital during the sample period, and no patient underwent open repair during the period.No 30-day mortality or femoral or brachial access site complications.No patient required venous intervention.The 1-year primary patency was 100 percent.However, there was one late graft thrombosis at 14 months for the patient (number 6) with two gore® viabahn® endoprostheses placed.This remained asymptomatic, and no further intervention has been required.No graft infections have been reported to date.

Manufacturer Narrative

Added method code 2 - device disposition.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10022832
• MDR Text Key: 194522006
• Report Number: 2017233-2020-00310
• 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
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR