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

Model Number	RLT261418
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imaging evaluation summary: non-contrast post-implantation computed tomography angiography images dated (b)(6) 2021 were returned to gore.The imaging evaluation showed the following: the right renal artery appears to be lowest by axial imaging.The aortic diameter just distal to the right renal artery appears to be 21.1mm.Images distal to the flow divider appear to show aortic diameters to be 20.5mm ¿ 22.3mm.Aortic diameters appear to narrow to ~19mm between the flow divider and the aortic bifurcation.The ipsilateral leg appears to be compressed at the level of the aortic bifurcation.The flow lumen diameter cannot be confirmed without contrast.The possibility of a dissected vessel cannot be ruled out without contrast.The ipsilateral limb appears to be opened extending into the right common iliac artery.
Event or Problem Description
On (b)(6) 2021, this patient underwent an endovascular procedure and was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.The patient reportedly presented with an aortic diameter measuring 21 mm.On (b)(6) 2021, follow-up computed tomography imaging revealed a compression of the ipsilateral leg of the implanted gore® excluder® aaa endoprosthesis rlt261418.Reportedly, there is bloodflow towards distal and there appears to be no thrombus.It seems the ipsilateral leg is compressed at the level between the flow divider and the contralateral leg hole where the contralateral leg component joins as well as distally.The physician has taken a wait - and - watch approach as the patient is reportedly asymptomatic.The fsa stated that images would be available.
Additional Manufacturer Narrative
H6, medical device problem code: added code 2682.H6, component code: added code 515.H6, investigation findings: added code 3211.H6; investigation conclusions: added codes 4315, 22, 50.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12669441
• Report Number: 3007284313-2021-01627
• Device Sequence Number: 14506034
• Product Code: MIH
• UDI-Device Identifier: 00733132622474
• UDI-Public: 00733132622474
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2024
• Device Model Number: RLT261418
• Device Catalogue Number: RLT261418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 87 KG