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

Catalog Number	PXT261416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imaging evaluation results: on (b)(6) 2016, cta images appeared to show contrast in the proximal left/anterior aneurysm sac and bright densities at the anterior sac probably caused by previous vessel embolization.It also showed a questionable area of possible contrast outside the implanted device, more distal in the aneurysm sac but appears to not be contrast on comparison images.On (b)(6) 2018, cta images appeared to show an area of questionable contrast outside the implanted devices near the vessel embolization.It appears to not be contrast on comparison images.Comparison axial images of (b)(6) 2016, (b)(6) 2018 & (b)(6) 2019 cta images appear to show contrast in the left/anterior aneurysm sac on the (b)(6) 2016 time point only.Max aneurysm diameters were listed as (b)(6) 2016 ¿ 76.0 mm x 87.3 mm, (b)(6) 18 ¿ 78.2 mm x 90.8 mm and (b)(6) 2019 ¿ 85.0 mm x 94.9 mm.There appears to be aneurysmal growth.Angiogram images dated (b)(6) 2019 are secondary captured images without contrast runs.Final image appears to show an aortic extender and an endologic ovation® graft with polymer rings implanted in addition to the original excluder® device.Medications - lipitor, asa, tessalon, zetia, synthroid, prinzide & singular.Co-morbidities - copd, cad & pulmonary hypertension.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.As stated in the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to endoleaks.
Event or Problem Description
On (b)(6) 2017 the patient presented with an abdominal aortic aneurysm which was treated with two gore® excluder® aaa endoprostheses.On (b)(6) 2019 the physician reported the patient had a type v endoleak.It was reported that the aneurysm sac had expanded to 9.8 cm.The physician reportedly relined the existing gore® excluder® aaa endoprostheses.Imaging evaluations state the final image appears to show an aortic extender and an endologic ovation® graft with polymer rings implanted in addition to the original excluder® device.No further endoleaks were observed and the patient reportedly tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8723906
• Report Number: 2953161-2019-00046
• Device Sequence Number: 16576430
• Product Code: MIH
• UDI-Device Identifier: 00733132610235
• UDI-Public: 00733132610235
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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: 07/31/2010
• Device Catalogue Number: PXT261416
• Device Lot Number: 05295334
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2019
• 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; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 79