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

Catalog Number	RMT311417
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pxc201400/9437286 udi (b)(4).The review of the manufacturing paperwork verified that these lots met all pre-release specifications.
Event or Problem Description
On (b)(6) 2011, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported computed tomography images (date unknown), revealed there is a proximal type i endoleak with aneurysm sac enlargement.There is also enlargement of the left common iliac artery aneurysm (treated area) and a distal type i endoleak (previously implanted pxc201400/9437286).Possible reintervention on (b)(6) 2018.
Event or Problem Description
On (b)(6) 2011, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported computed tomography images dated (b)(6) 2018, revealed there is a proximal type i endoleak with aneurysm sac enlargement.There is also enlargement of the left common iliac artery aneurysm (treated area) and a distal type i endoleak (previously implanted pxc201400/9437286).The physician reintervened on (b)(6) 2018, and three additional devices were implanted (ceb231210a/17637894, pla360400/15075132, and plc231000/17837814).The endoleak was resolved and the patient tolerated the reintervention.
Additional Manufacturer Narrative
Addition d11: patient medications: amiodarone, aspirin, carvedilol, clopidogrel, coreg, coumadin, levothyroxine, nitroglycerin, rosuvastatin.

• 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: 7917169
• Report Number: 2017233-2018-00579
• Device Sequence Number: 2305198
• Product Code: MIH
• UDI-Device Identifier: 00733132610761
• UDI-Public: 00733132610761
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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: 07/31/2014
• Device Catalogue Number: RMT311417
• Device Lot Number: 9504584
• 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
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 11/07/2018
• 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: Other
• Patient Age: 77 YR
• Patient Weight: 98