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

Model Number	PXT281416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2010, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that the patient has significant migration of her gore® excluder® aaa endoprostheses (computed tomography dated (b)(6) 2021).The aneurysm starts almost immediately below the renal arteries.There is no aneurysm sac enlargement.A future reintervention is being considered, utilizing a fenestrated/branch graft (non gore device) repair.The event is ongoing.
Additional Manufacturer Narrative
H6: code: 213: no device problem found, code 4315: cause not established, code 4117 replaced with code 4112 as imaging was received for evaluation.Imaging evaluation: the aortic diameters within the proximal 8mm ~26mm, the infra-renal aortic diameter @15mm ~36mm (average), the previously implanted endograft appears to be approximately 52mm distal to the lowest renal artery.No pre-implantation images are available to assess diameters and lengths.The aorta appears tortuous.There is no evidence of graft kinking or abnormality within the graft excluding the fact that it appears 5cm distal to the lowest renal artery.The left and right hypogastric arteries appear to be patent.There does not appear to be any evidence of a type 1b endoleak.

• 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
• MDR Report Key: 11645899
• Report Number: 2953161-2021-01058
• Device Sequence Number: 11525412
• Product Code: MIH
• UDI-Device Identifier: 00733132610310
• UDI-Public: 00733132610310
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 11/30/2012
• Device Model Number: PXT281416
• Device Catalogue Number: PXT281416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 06/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR