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

Catalog Number	PXT261216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pxc121200/7483468 udi: (b)(4).Patient medications: zebeta, mobic, and losartan.
Event or Problem Description
On (b)(6) 2011, this patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported computed tomography images dated (b)(6) 2019, revealed there is a possible type i b endoleak (unknown if on the ipsilateral or contralateral limb) which is causing aneurysm sac enlargement.Reportedly there were past attempts at embolization, the field sales associate was not present and not aware of any intervention¿s until notified by a new physician that is new to the patient, follow up visit on (b)(6) 2019.It was reported there were two other embolization procedures and it is unknown what type of endoleak the physician was attempting to treat.On (b)(6) 2019, there was a reintervention and coil embolization of the iliolumbar junction due to the sac continuing to grow (aneurysm sac enlargement amount is unknown).On (b)(6) 2019, the physician performed a lumbar puncture and filled the aneurysm sac with glue.The patient tolerated these procedure but the aneurysm sac continued to grow (amount of growth is unknown).On (b)(6) 2019, the physician reintervened and implanted two additional devices, one in each iliac artery to extend the implanted grafts and more coiling was performed.The patient tolerated the reintervention.

• 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: 9379031
• Report Number: 2953161-2019-00064
• Device Sequence Number: 16659281
• Product Code: MIH
• UDI-Device Identifier: 00733132610198
• UDI-Public: 00733132610198
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 10/29/2019

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: 09/30/2011
• Device Catalogue Number: PXT261216
• Device Lot Number: 06366681
• 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: 11/26/2019
• 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; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 82