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

Catalog Number	PLC231000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: plc231000/13731351.Udi: ((b)(4).Imaging evaluation: images were sent to gore imaging services for evaluation.Per the evaluation images dated (b)(4) 2019, there appears to be contrast outside of the implanted device.Unable to confirm origin of endoleak.The length of overlap between the bridging component and the ibe component appears to be ~12mm.There appears to be patent lumbar arteries.The review of the manufacturing paperwork verified that these lots met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.The instructions for use provide the following warning among others: ¿adverse events that may occur and/or require intervention include, but are not limited to: endoleak¿.
Event or Problem Description
On (b)(6) 2017, this patient underwent endovascular treatment for an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses, and treatment of bi-lateral iliac aneurysms treated with gore® excluder® iliac branch endoprostheses.It was reported that an endoleak (unknown type and unknown from which device) was reported on computed tomography images dated (b)(6) 2019.The physician claimed either a type iii endoleak between the ibe bridge components (ceb231210a/16550024 and plc231000/13731351 or plc231000/17275880) due to insufficient overlap of the devices in the original procedure or possibly a type ii endoleak.The physician reintervened on (b)(6) 2016, and relined the aortic excluder iliac branch endoprosthesis and contralateral leg endoprosthesis with an additional contralateral leg endoprosthesis, due to the iliac artery aneurysm growing (amount of growth is unknown).The physician is taking a wait and watch approach for a possible type ii endoleak.The patient tolerated the reintervention.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8680849
• Report Number: 3013164176-2019-00063
• Device Sequence Number: 2021454
• Product Code: MIH
• UDI-Device Identifier: 00733132618576
• UDI-Public: 00733132618576
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2019

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: 09/25/2020
• Device Catalogue Number: PLC231000
• Device Lot Number: 17275880
• 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: 06/07/2019
• 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: 62 YR