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

Device Problem No Apparent Adverse Event (3189)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/01/2014

Event Type  Death  

Manufacturer Narrative

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

This event was received through literature article "outcomes of unilateral versus bilateral use of the iliac branch endoprosthesis for elective endovascular treatment of aorto-iliac aneurysms" published in cardiovascular interventional radiology 2-jun-2022.The purpose of the study was to evaluate outcomes after bilateral implantation of the gore excluder iliac branch endoprosthesis (ibe) versus those achieved after unilateral implantation.In this retrospective study, a total of 74 patients were included.The patients were 97% male, mean age 74=/- 7 years.The procedures were performed over a period of 5 years, between 1-jan-2014 and 31-dec-2018.Thirteen patients, (17%) received bilateral ibe implantation for a total of 85 vessels evaluated.Technical success rate was 97% and was not significantly different between the two groups.There were two technical failures, one in each group, due to inability to catheterize the target vessel which was therefore embolized and covered.Two patients died within 30 days, both in the unilateral group.There were three cases of buttock claudication, with two cases occurring in the bilateral group, and the other in the unilateral group.In the bilateral group, one event was due to intraoperative technical failure (inability to catheterize the posterior division branch.The second case in the bilateral group occurred within 6 months of the index procedure in a patient with thrombosis of the ibe internal iliac component.No reintervention was performed.One patient in the unilateral group who had contralateral coiling and coverage of the internal iliac later developed buttock claudication symptoms on that side.The article concludes that bilateral ibe used for elective endovascular treatment of aorto-iliac aneurysms appears safe and feasible and may achieve satisfactory short-term and mid-term outcomes.Bilateral ibe use should be employed judiciously in the context of a comprehensive risk/benefit evaluation.Code 1001-e: unknown - unknown patient death.

Manufacturer Narrative

Additional investigation determined no product problem or deficiency caused or contributed to an adverse event/incident for the patient; the initial medwatch and any supplemental report submitted under manufacturer report number 3013164176-2023-01621 was submitted in error and is hereby retracted.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16452832
• MDR Text Key: 310345750
• Report Number: 3013164176-2023-01621
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• 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: 02/01/2023
• 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): Death; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male