MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	RMT261414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/14/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 aneurysm enlargement.
Event or Problem Description
The patient referenced in this event file is enrolled in a post market prospective observational cohort registry designed to obtain data on device performance and clinical outcomes of patients treated with gore endovascular aortic products through the global registry for endovascular aortic treatment (great).On (b)(6) 2014, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm, asd well as right and left common iliac artery aneurysms.The patient tolerated the initial procedure.The maximum diameter of the aortic aneurysm was 53mm by ultrasound.On (b)(6) 2014 follow-up computed tomography angiography (cta) showed the maximum aortic diameter of the aortic aneurysm was 49mm.On (b)(6) 2015 follow-up cta showed the maximum diameter of the aortic aneurysm was 53mm.On (b)(6) 2018 a type i endoleak was found.On (b)(6) 2018, the maximum aortic diameter of the aortic aneurysm was 56mm by ultrasound.On (b)(6) 2018, the maximum aortic diameter of the aortic aneurysm by cta was 60mm.The event is ongoing.
Additional Manufacturer Narrative
H.6.Conclusion code 1: 22: 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 aneurysm enlargement.
Event or Problem Description
The patient referenced in this event file is enrolled in a post market prospective observational cohort registry designed to obtain data on device performance and clinical outcomes of patients treated with gore endovascular aortic products through the global registry for endovascular aortic treatment (great).On (b)(6), 2014, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm, as well as right and left common iliac artery aneurysms.The patient tolerated the initial procedure.The pre-treatment maximum diameter of the aortic aneurysm was 53mm by ultrasound.The completion angiogram showed a proximal type i endoleak, so the device was post-dilated more aggressively with a 250mm balloon, which improved the leak substantially.There was still a faint type i endoleak, with some filling of the ima, mid sacral and some lumbar arteries.This was thought to be helpful since much of the pelvic perfusion was being removed.The plan was to allow this filling to close after the heparin was reversed and minimize any pelvic ischemia if possible.On (b)(6), 2014 follow-up computed tomography angiography (cta) showed the maximum aortic diameter of the aortic aneurysm was 49mm.On (b)(6), 2015 follow-up cta showed the maximum diameter of the aortic aneurysm was 53mm.On (b)(6), 2018 a type i endoleak was seen.On (b)(6), 2018, the maximum aortic diameter of the aortic aneurysm was 56mm by ultrasound.On (b)(6), 2018, the maximum aortic diameter of the aortic aneurysm by cta was 60mm.On (b)(6), 2019, it was reported the proximal type i endoleak had resolved, however a type ii endoleak was noted.There has been no reintervention.
Additional Manufacturer Narrative
B.6.Imaging evaluation results: summary: ¿ two time-points available for evaluation: post-implantation cta dated (b)(6) 2014 and post-implantation cta dated (b)(6) 2015.¿ on the (b)(6) 2014 time-point: o there appears to be contrast pooling outside the implanted device.O anterior pooling contrast appears to communicate with contrast in the ima.O contrast pooling posteriorly appears to communicate with contrast in a set of lumbar arteries.Cannot confirm ante grade or retrograde flow, with available images.¿ on the (b)(6) 2015 time-point: o there appears to be contrast pooling in the posterior sac outside the implanted device on this time-point.O there appears to be contrast in a set of lumbar arteries at this level.O probable type ii endoleak.O comparison axial images from both time-points appear to show: o maximum aaa diameters: (b)(6) 2014 - 49.8mm x 52.8mm; (b)(6) 2015 - 52.6mm x 55.1mm.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8857396
• Report Number: 3007284313-2019-00237
• Device Sequence Number: 14052663
• Product Code: MIH
• UDI-Device Identifier: 00733132610631
• UDI-Public: 00733132610631
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2019

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 Expiration Date: 10/31/2016
• Device Catalogue Number: RMT261414
• Device Lot Number: 12015034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 09/23/2019; 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 69 YR
• Patient Weight: 99