MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Device Problem Positioning Failure (1158)

Patient Problem Obstruction/Occlusion (2422)

Event Date 05/20/2023

Event Type  Injury  

Event Description

The following literature was reviewed.Title: usefulness of evar (aorto-uni-iliac) with gore excluder takumi sugiura, et al.The official journal of the japanese society of interventional radiology 2023: 38(suppl.) p.314 aorto-uni-iliac (aui) procedure using gore® excluder® aaa endoprosthesis may have to be chosen in case of some anatomical conditions, emergency cases, social situations, or in times of trouble.5 cases at a single facility from january 2014 to december 2022, where evar using gore® excluder® aaa endoprosthesis were converted to aorto-uni-iliac (aui) using aortic extender (cuff) or contralateral leg (leg) in the excluder main body, were reviewed.The reasons for aui conversion, the methods used, the presence of endoleaks, and the patient outcome were examined.Results: all patients were treated for abdominal aortic aneurysms, 3 emergency cases (2 ruptured, 1 impending rupture) and 2 scheduled cases.4 cases were treated with a cuff in the main body for aui and 1 case with the leg upside down.Two rupture cases were in shock.In all cases, evar was completed with aui.One of the scheduled cases was considered difficult to use an endurant aui because the proximal landing zone was highly angulated, and the other case was difficult to cannulate the contralateral gate because it was embedded in a mural thrombus.One of the emergency cases had a long occlusion of the iliac artery on one side, and the other two cases had difficulty in cannulating the contralateral gate.Except for one ruptured patient who died the same day, all patients had no type iii endoleak on postoperative contrast-enhanced ct and no subsequent aneurysm-related death or evar-related complications.

Manufacturer Narrative

H.6.Type of investigation code b22: a review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.H.6.Investigation findings code c20: the device remains implanted and is not available for analysis.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.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17871955
• MDR Text Key: 324934797
• Report Number: 3007284313-2023-02802
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2023

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: 09/07/2023
• Initial Date FDA Received: 10/04/2023
• 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): Other