MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight info and implanted date are not available.

Event Description

The following information was received through literature ¿outcomes of hybrid procedure for type b aortic dissection with an aberrant right subclavian artery¿ published in journal of vascular surgery.The study aimed to report hybrid procedure for type b aortic dissection (tbad) with an aberrant right subclavian artery (arsa) and the early to midterm outcomes in these patients.From december 2011 to february 2016, 16 patients underwent tevar (non gore devices) and anatomic bypass hybrid procedure (gore-tex vascular grafts and gore-tex suture were used).No.6 patient's mid-term outcomes lcca-lsa (lcca: left common carotid artery; lsa: left subclavian artery) bypass occlusion, patients left untreated with no symptoms.

Manufacturer Narrative

Article citation: outcomes of hybrid procedure for type b aortic dissection with an aberrant right subclavian artery.Huanyu ding, songyuan luo, yuan liu, jianfang luo, et al.Http://dx.Doi.Org/10.1016/j.Jvs.2017.07.124.Journal of vascular surgery volume 67, issue 3, pages 711-712.A review of the manufacturing records for the device was unable to be conducted as no lot number was available.

• Brand Name: GORE-TEX VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12022837
• MDR Text Key: 264701626
• Report Number: 2017233-2021-02092
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• 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: 05/20/2021
• Patient Sequence Number: 1
• Treatment: LIFETECH ANKURA 30*200
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR