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

Model Number	RLT261216
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	06/04/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The following article was reviewed: elizabeth a.Andraska, et al (2022) ¿longer follow-up intervals following endovascular aortic aneurysm repair are safe and appropriate after marked aneurysm sac regression, journal of vascular surgery, volume 76, issue 2, august 2022, pages 454-460.(https://www.Sciencedirect.Com/science/article/pii/s0741521422001926) https://doi.Org/10.1016/j.Jvs.2022.01.079 this was a multihospital single-institution retrospective cohort study.Elective infrarenal evars performed between 2008 and 2011 were retrospectively reviewed.Aaa sac diameters using the minor axis measurement from ultrasound imaging or computer tomography angiogram imaging were compared with the baseline diameter from the 1-month postoperative computer tomography angiogram.The primary outcome was a composite of freedom from postoperative reintervention or rupture.We compared those with aaa sacs who regressed to predefined minimum diameter thresholds with those who did not.Outcomes were plotted with kaplan-meier curves and compared using log-rank testing and fine-gray regression using death as a competing risk, clustered on graft type.For patients whose aaa reached the minimum sac diameter, landmark analysis evaluated ongoing size changes including further regression and sac re-expansion.A total of 540 patients (aged 75.1 ± 8.2 years; 82.0% male) underwent evar with an average preoperative aaa size of 55.2 ± 11.5 mm.Most patients had a gore® excluder® aaa endoprostheses, 344 of 540 patients.The median postoperative follow-up was 5.3 years during which 64 patients underwent reintervention and 4 ruptured.Aaa sac regression to =40 mm in diameter was associated with improved freedom from reintervention or rupture overall, which was maintained after controlling for the competing risk of death.In 376 patients whose aneurysm sac remained >40 mm, 99 reinterventions were performed on 63 patients.Of 166 patients whose sac regressed to =40 mm, only 1 patient required a reintervention, and no one ruptured.The mean time to a diameter of =40 mm was 2.3 ± 1.9 years.Only eight patients developed sac re-expansion to >45 mm; all but two occurred at least 3 years after initially regressing to =40 mm.In total, 100 reinterventions including diagnostic angiograms were performed on 64 patients during the period of follow-up: 39 procedures involved coil embolization and 37 a proximal or distal graft extension.There were four ruptures ; three of these patients were lost to follow-up and ruptured at least 5 years postoperatively.In long-term follow-up, patients whose minimum aaa sac diameter regressed =40 mm after evar experienced a very low rate of reintervention, rupture, or sac re-expansion.Most sac re-expansion occurred at least 3 years after reaching this threshold and did not result in clinical events.Increasing follow-up frequency up to 3-year intervals once the aaa sac regresses to 40 mm would carry minimal risk of aneurysm-related morbidity.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: 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 WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17240723
• Report Number: 2017233-2023-04077
• Device Sequence Number: 6698230
• Product Code: MIH
• UDI-Device Identifier: 00733132622429
• UDI-Public: 00733132622429
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2023

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
• Operator of Device: Health Professional
• Device Model Number: RLT261216
• Device Catalogue Number: RLT261216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2023
• Initial Report FDA Received Date: 06/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male