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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Occlusion (1984); Perforation (2001)

Event Date 01/01/2020

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: "off-the-shelf devices for treatment of thoracic aortic diseases: midterm follow-up of tevar with chimneys or physician-made fenestrations" received through "journal of endovascular therapy 2020, vol.27(1) 132¿142".The authors: lei zhang, md, phd, meng-tao wu, md, phd, guang-lang zhu, md, et al.The article aimed to evaluate the midterm outcomes of thoracic endovascular aortic repair (tevar) using chimney grafts (ch-tevar) or thoracic stent-grafts with fenestrations made on the back table (f-tevar) to treat thoracic aortic dissection (tad) and thoracic aortic aneurysm (taa).A retrospective analysis was conducted of 474 consecutive patients (mean age 62.3±10.7 years; 346 men) treated with either f-tevar (n=110) or ch-tevar (n=364) for 352 tads (81 f-tevar and 271 ch-tevar) or 122 taas (29 f-tevar and 93 ch-tevar) from 2008 to 2016.Tag was used in ch-tevar(96/364), viabahn was used in f-tevar(29/75) and in ch-tevar(260/518).The results stated one hundred (16.9%) of the 593 branch stents occluded (4/75 in the f-tevar group and 96/518 in the ch-tevar group, p<0.01).Of the 62 (13.1%) patients with branch occlusion, 28 were asymptomatic, and no reintervention was performed (7.2% branch reintervention rate).The branch reintervention rate was 7.2% (34/474).

• 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: 10498439
• MDR Text Key: 208792215
• Report Number: 2017233-2020-01239
• 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: 09/07/2020

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: 08/14/2020
• Initial Date FDA Received: 09/06/2020
• 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: 62