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

Model Number	PXT231214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2007, this patient underwent an endovascular treatment for an 45mm abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.The trunk-ipsilateral leg endoprosthesis was implanted from the right side.The contralateral leg and an iliac extender were placed from the left side.A covered stent (atrium advanta v12, 6 mm x 38 mm) was implanted in the right internal iliac artery.At a follow up on an unknown date, the aneurysm sac size measured 24 mm.In 2016, follow up showed aneurysm enlargement.On an unknown date in (b)(6) 2021, the aneurysm measured 55 mm and an additional procedure was indicated.On (b)(6) 2021, angiography was performed as a type ii endoleak or distal type i endoleak from the right side was suspected.The angiogram showed a distal type i endoleak but type ii endoleak was not obvious.To resolve the distal type i endoleak, the right internal iliac artery was embolized and an additional iliac extender endoprosthesis (pll161207j) was implanted into the right common iliac artery.The treatment area was extended to the external iliac artery.The patient tolerated the procedure.

• 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
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12830672
• Report Number: 2017233-2021-02546
• Device Sequence Number: 19899831
• Product Code: MIH
• UDI-Device Identifier: 00733132610105
• UDI-Public: 00733132610105
• 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: 2007
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

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: 07/31/2010
• Device Model Number: PXT231214
• Device Catalogue Number: PXT231214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/17/2021
• Date Device Manufactured: 08/09/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male