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

Device Problem Material Puncture/Hole (1504)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

It was confirmed that the device was gore® viabahn® endoprosthesis and size was 6mm*10cm.Due to an unknown lot/serial number and no device return, an investigation could not be performed.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The following information was received through literature ¿physician-modified branched double-trunk stent-graft (pbds) for thoracoabdominal aortic aneurysm¿ published by heart, lung and circulation, volume 30, issue 6, 2021, pages 896-901.The study was to describe the preliminary experience of using physician-modified, branched, double-trunk stent-grafts (pbds) for treating thoracoabdominal aortic aneurysms (taaa).Viabahn stent-grafts (w.L.Gore, flagstaff, az, usa) were tailored and sewn clockwise onto each pbds to get close to the origin of the visceral arteries at different locations.The results state there was one type iii endoleaks detected intraoperatively and was embolised with onyx (medtronic, irvine, ca, usa).The endoleaks disappeared during follow-up.One (1) patient experienced renal artery occlusion (two renal stent-graft occlusions) 10 months later and was treated with additional stent-graft implantation.

Manufacturer Narrative

Citation: zhaoxiang zeng, yuxi zhao, aikebaierjiang ainiwaer, mingwei wu, xianhao bao, tao li, jiaxuan feng, rui feng, zaiping jing, physician-modified branched double-trunk stent-graft (pbds) for thoracoabdominal aortic aneurysm, heart, lung and circulation, volume 30, issue 6, 2021, pages 896-901, issn 1443-9506.

• 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: 15196512
• MDR Text Key: 297569056
• Report Number: 2017233-2022-03199
• 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: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2022

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: 07/27/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 08/18/2022; 08/19/2022
• Supplement Dates FDA Received: 08/17/2022; 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 56 YR
• Patient Sex: Male