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

Catalog Number	RLT351414
Medical Device Problem Codes	Microbial Contamination of Device (2303); Device Endoleak (4074)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on september 25, 2019, a patient presenting with an abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.Six weeks post operatively, the patient presented with skin lesions.Computed tomography (ct) imaging showed successful exclusion of the aortic aneurysm and no endoleaks.On (b)(6) 2020, ct imaging showed an increase of aneurysm diameter.No measurement given.In (b)(6) 2021, maximum aneurysm diameter increased to 7 cm.An endoleak was visible posteriomedial aspect of the iliac limb.It was decided that the patient was presenting with a type ii endoleak.In (b)(6) 2021, the patient was successfully treated with onyx embolic material.
Additional Manufacturer Narrative
D10: gore® excluder® aaa endoprosthesis stent graft contralateral leg plc231000 lot no.18579251 gore® excluder® aaa endoprosthesis stent graft contralateral leg plc161200 lot no.17460605 gore® excluder® aaa endoprosthesis stent graft contralateral leg plc161000 lot no.18001832 h3: evaluation is in progress 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.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met pre-release specifications.The imaging evaluation performed by a clinical imaging specialist showed the following: six timepoints available for evaluation: (b)(6) 2019-pre-implant cta: max diameter measures 64.4 mm x 65.4 mm.A distal left accessory renal, patent ima and lumbars are visible.(b)(6) 2019-arterial phase only: max diameter measures 66.4 mm x 67.4 mm.There are patent lumbar arteries present and a contrast-like density seen outside of the implanted device.Unable to confirm contrast without a non-contrast study for comparison.(b)(6) 2021-non-contrast, arterial and delay phases: max diameter measures 68.6 mm x 69.9.Contrast is present outside of the device on the arterial and delay phases.Possible patent ima and patent lumbar arteries are visible.(b)(6) 2021-procedural angiograms: multiple selective lumbar artery angiogram views available.There appears to be contrast outside of the implanted device upon injection of contrast.The ima and lumbar arteries have been embolized.(b)(6) 2021-arterial and delay phases: max diameter measures 69.6 mm x 74.3 mm.There is contrast visualized outside of the implanted device on the delay phase.The ima and lumbar arteries have been embolized.(b)(6) 2020-pet ct max diameter measures 73.7 mm x 71.2 mm.Ima and lumbars are embolized.Findings are consistent with the reported type ii endoleak.
Additional Manufacturer Narrative
A review of the manufacturing and sterilization records indicated the lot met pre-release specifications.The imaging evaluation performed showed the following: six timepoints available for evaluation: (b)(6) 2019-pre-implant cta: max diameter measures 64.4 mm x 65.4 mm.A distal left accessory renal, patent ima and lumbars are visible.Pages 4-5.(b)(6) 2019-arterial phase only: max diameter measures 66.4 mm x 67.4 mm.There are patent lumbar arteries present and a contrast-like density seen outside of the implanted device.Unable to confirm contrast without a non-contrast study for comparison.Pages 6-7 (b)(6) 2021-non-contrast, arterial and delay phases: max diameter measures 68.6 mm x 69.9.Contrast is present outside of the device on the arterial and delay phases.Possible patent ima and patent lumbar arteries are visible.Pages 8-10.(b)(6) 2021-procedural angiograms: multiple selective lumbar artery angiogram views available.There appears to be contrast outside of the implanted device upon injection of contrast.The ima and lumbar arteries have been embolized.Pages 11-14.(b)(6) 2021-arterial and delay phases: max diameter measures 69.6 mm x 74.3 mm.There is contrast visualized outside of the implanted device on the delay phase.The ima and lumbar arteries have been embolized.Pages 15-17.(b)(6) 2020-pet ct max diameter measures 73.7 mm x 71.2 mm.Ima and lumbars are embolized.Pages 18-19.Findings are consistent with the reported type ii endoleak.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include but are not limited to endoleak and device infection.
Event or Problem Description
It was reported that on (b)(6) 2019, a patient presenting with an abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.Six weeks post operatively, the patient presented with skin lesions.Computed tomography (ct) imaging showed successful exclusion of the aortic aneurysm and no endoleaks.On (b)(6) 2020, ct imaging showed an increase of aneurysm diameter.No measurement given.In (b)(6) 2021, maximum aneurysm diameter increased to 7 cm.In (b)(6) 2021, an endoleak was visible at the posteriomedial aspect of the iliac limb arising from right l2, l3 and l4 lumbar arteries.An endoleak type ii was concluded.In (b)(6) 2021, the endoleak type ii was resolved with onyx embolic material during an endovascular reintervention.On (b)(6) 2021, the patient presented with weight loss, loss of appetite and abdominal pain.New fat stranding was present in the abdominal aorta and iliac arteries and para-aortic lymphadenopathy was noted.These findings have been reported to be consistent with acute aortitis.Furthermore, a persistent endoleak type ii arising from l4 lumbar arteries was noted.Blood cultures dated (b)(6) 2021, have been reported to be positive for staphylococcus capitis.Blood cultures dated (b)(6) 2021, have been reported to be positive for gram-positive cocci.The cause of the infection was reported to be unknown.In (b)(6) 2021, pet ct showed a diffuse fdg uptake within the walls of the aneurysmal sac, no fdg uptake in relation to the stent was noted.In (b)(6) 2021, it was decided to carry out long-term antibiotic suppression as the patient was not considered fit enough for explantation.
Additional Manufacturer Narrative
The investigation conclusion code 'd16' was added to the most recent follow-up medwatch in error.The corrected code, 'd12,' has been submitted with this medwatch.No other changes have been made.

• 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 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: 18968132
• Report Number: 3007284313-2024-03131
• Device Sequence Number: 17716903
• Product Code: MIH
• UDI-Device Identifier: 00733132618477
• UDI-Public: 00733132618477
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/18/2024

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
• Device Expiration Date: 04/02/2022
• Device Catalogue Number: RLT351414
• 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: 03/20/2024
• Supplement Date Received by Manufacturer: 04/04/2024; 08/21/2024; 09/18/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/04/2024; 08/22/2024; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Male