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

Device Problems Obstruction of Flow (2423); Migration (4003)

Patient Problems Ruptured Aneurysm (4436); Thrombosis/Thrombus (4440)

Event Date 12/31/2017

Event Type  Injury  

Event Description

The following literature article was reviewed: väärämäki, s., uurto, i.And suominen, v., 2023.Possible implications of device-specific variability in post-evar sac regression and endoleaks for surveillance categorization.Journal of vascular surgery, pp.S0741-5214.Doi.Org/10.1016/j.Jvs.2023.07.001.Significant sac regression during early surveillance has been shown to best predict reintervention-free long-term surveillance after endovascular aneurysm repair (evar).Furthermore, a persistent endoleak has been related to a worse outcome.The objective of this study was to evaluate device-specific differences in sac regression and endoleaks during post-evar surveillance and to determine how these may affect the patients¿ categorization for individualized surveillance.This retrospective study included all patients assigned to elective treatment of an abdominal aortic aneurysms (aaa) using standard evar in one academic institution between 2005 and 2015, comprising a total of 435 patients.The initial indication for treatment was an aneurysm with a diameter of 55 mm or greater in men and 50 mm or greater in women, or an increase of 5 mm in diameter over a period of 6 months.Patients were treated with three different stent grafts: endurant (medtronic), gore® excluder® aaa endoprosthesis (w.L.Gore & associates), and zenith (cook inc).After institutional approval of the study, data were collected retrospectively through a review of electronic medical records.One hundred-fifty patients were treated with the gore® excluder® device.132 of these were male and the average age of the patient was 76.1 years old.At the 30 day follow up, the detected endoleak included type i and ii.An endoleak was found most often with the gore® excluder® stent graft (33.6%).Of these endoleaks associated with the gore® excluder®, 5 were type i and 44 were type ii.At 2 years, 53.5% of the patients (185) showed an at least 5-mm sac regression when compared with the pre- operative cta.The median shrinkage was 11.0 mm among all evar patients who had any sac regression at 2 years.There was no significant difference in sac shrinkage rate between the devices.Of the patients with no endoleak at 2 years, 11.8% developed a complication requiring a reintervention during further surveillance.Four patients who were initially treated with an gore® excluder® device had a shrinking aneurysm sac with an endoleak at 2 years.Three of these patients required reinterventions during further surveillance.A positive endoleak finding combined with positive sac regression was not found with any other device model.Other findings included endoleaks type 1a, 1b, and ii, thrombosis, migration, and patients that went on to have a ruptured aaa.Some of these resulted in reintervention and conversion to surgical procedure.There was a significant difference in endoleak rate at 30 days and 2 years between the devices.There are significant differences in the prevalence of endoleaks between devices at 30 days and 2 years, but there is no difference in sac regression.Patients with sac regression of less than or equal to 5 mm and no endoleaks in the 2-year cta can be safely categorized for infrequent surveillance regardless of the stent graft model that has initially been used.

Manufacturer Narrative

Device locations unknown.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: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18990491
• MDR Text Key: 338782818
• Report Number: 3007284313-2024-03140
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 03/28/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 03/28/2024
• 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
• Patient Age: 76 YR
• Patient Sex: Male