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

Model Number	PXT231418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All devices will be included as possibly contributory in the final medwatch.Additional devices implanted and/or related to this event: pxc141200/ 9739928, udi (b)(4).The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to endoleak and component migration.
Event or Problem Description
On (b)(6) 2012, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported that after all devices were implanted, a distal type i endoleak from the contralateral leg endoprosthesis in the right limb was observed.A stent (palmaz) was implanted distally of the contralateral leg endoprosthesis.However the distal type i endoleak remained.The physician decided to monitor it.On an unknown date in (b)(6) 2020, a follow-up ct imaging identified the distal type i endoleak from the right leg remained and migration (distance unknown) of the trunk ipsilateral leg endprosthesis.On (b)(6) 2020, a reintervention procedure was performed.The right internal iliac artery was embolized as planned.Then, an iliac extender endoprosthesis was implanted in the right external iliac artery.Two aortic extender endoprostheses were implanted proximal of the trunk ipsilateral leg endoprosthesis.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition h6: code 216-the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Addition h6: code 22-the gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to endoleak and component migration.
Additional Manufacturer Narrative
Addition g5.

• 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: 10564314
• Report Number: 2953161-2020-01020
• Device Sequence Number: 1167684
• Product Code: MIH
• UDI-Device Identifier: 00733132610167
• UDI-Public: 00733132610167
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2021

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: No Information
• Device Expiration Date: 07/31/2014
• Device Model Number: PXT231418
• Device Catalogue Number: PXT231418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020; 08/28/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 12/22/2020; 01/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR