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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, an investigation of the device cannot be performed.Problem due to thrombosis activation.The author stated that at follow-up the patient was discharged on aspirin.As the lot / serial no.Remains unknown, a review of the manufacturing records for the device could not be conducted.

Event Description

The following publication was reviewed: carotid-axillary bypass as an alternative revascularization method for zone ii thoracic endovascular aortic repair from oana bartos et al.Published in the journal of vascular surgery on february 20, 2020, (volume 72, pages 1229-36).The background of the study is to investigate the mid-term results of carotid-axillary bypass (cab) in the setting of zone ii thoracic endovascular aortic repair as an alternative method for the left subclavian artery (lsa) revascularization.The retrospective, single cohort study included overall 69 patients from march 2015 to december 2018.All patients were treated with a carotid-axillary bypass (cab) and zone ii tevar in the same session.In all cases, a 6-mm ringless gore-tex¿ vascular graft was implanted.The following adverse events was reported in the article: 04419-1: bypass thrombosis was observed in two patients.Both patients with bypass thrombosis at follow-up were discharged on aspirin; in one patient, aspirin was discontinued by the general practitioner.In both cases, patients were symptomatic with claudication of the left arm after bypass thrombosis.

• 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
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11983486
• MDR Text Key: 266363851
• Report Number: 2017233-2021-02070
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2021

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: 05/18/2021
• Initial Date FDA Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: No
• 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: 64 YR