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

Model Number	RLT281418
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoleak and aneurysm enlargement.Furthermore, the ifu states that indications for use and appropriate anatomy for use of the trunk-ipsilateral leg endoprosthesis includes a minimum aortic neck length of 15 mm.The safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in patient populations including, but not limited to, patients with less than 15 mm in length.
Event or Problem Description
On (b)(6) 2017 the patient underwent endovascular treatment of an abdominal aortic aneurysm and bilateral common iliac artery aneurysms using gore® excluder® aaa endoprostheses.The patient's abdominal aortic aneurysm reportedly measured 6.5cm.It was reported that the patient did not have adequate proximal aortic neck length with which to land the device.Reportedly a type i endoleak was noted.The endoleak was monitored.On (b)(6) 2021 the patient presented to the emergency room with abdominal pain.The proximal type i endoleak remained and the abdominal aortic aneurysm had expanded to 7.5cm.It was noted that the patient's common iliac artery aneurysms had shrunk.The endoleak and subsequent aneurysm enlargement were reportedly attributed to the patient's anatomy.On the same day an intervention was performed.Gore® viabahn® vbx balloon expandable endoprostheses were placed in the patient's renal arteries.Two gore® excluder® aaa aortic extender components were placed from the patient's superior mesenteric artery down to the aortic bifurcation.The aneurysm was excluded.There were no further reported issues.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
• MDR Report Key: 11952248
• Report Number: 3007284313-2021-01456
• Device Sequence Number: 4242701
• Product Code: MIH
• UDI-Device Identifier: 00733132622559
• UDI-Public: 00733132622559
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 06/07/2021

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: 01/26/2019
• Device Model Number: RLT281418
• Device Catalogue Number: RLT281418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/07/2021
• 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: Required Intervention
• Patient Age: 73 YR