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 Bacterial Infection (1735)

Event Date 10/25/2020

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 ¿one-stage hybrid procedure for distal aortic arch disease: mid-term experience at a single center¿ published in journal of thoracic disease.The study analyzed the outcomes of a one-stage hybrid procedure combining thoracic endovascular aortic repair (tevar) with extra-anatomic bypass in patients with distal aortic arch disease from january 2009 to january 2019 at beijing anzhen hospital.30-day and mid-term outcomes was analyzed including survival rate and the incidence of stroke, spinal cord injury (sci), and endoleak.The bifurcate ¿t¿ or straight gore-tex® (w.L.Gore and ass., flagstaff, az, usa) prosthetic graft through a subcutaneous tunnel.The results state that one patient experienced a prosthetic graft infection followed by type i endoleak.But he refused reintervention and died due to aortic rupture.During 39.5 months of follow-up, only one patient experienced slight stenosis of the extra-anatomic bypass but no indication for reintervention.

Manufacturer Narrative

Add g4, h6.

• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11699031
• MDR Text Key: 259359532
• Report Number: 2017233-2021-01879
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male