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

Model Number	PLA360400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994)
Date of Event	07/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pla320400/ 12615065 udi (b)(4).Gore was unable to determine which of the implanted devices was involved in the event.According to md174141, when unable to determine which device/device component is involved in the reportable event, and the devices are of the same device family one device will be reported and the other devices will be referenced in the report.Patient medications: toprol-xl, ibuprofen, fiber flow oral, apresoline, catapres, norvasc, alka-seltzer, lipitor, synthroid, dulcolax, ambien, klonopin.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 aneurysm.
Event or Problem Description
The fsa reported: on (b)(6) 2015, the patient underwent endovascular treatment of a huge pseudoaneurysm at the proximal anastomosis of an old aorto-bi-iliac graft with erosion of the anterior spine with two different vertebrae.Three gore® excluder® aaa aortic extender endoprostheses were implanted.It was reported that on (b)(6) 2021, the patient presented with back pain.Computed tomography scans dated (b)(6) 2021, revealed the gore® excluder® aaa aortic extender endoprostheses appear to be creating pressure on the patient¿s anterior lumbar spine and causing erosion into the anterior aspect of it.This is a non-contrast scan and the physician is unable to determine if an endoleak is present.A reintervention is planned for the following week and a ct will be done with contrast and a possible realignment of the graft.
Additional Manufacturer Narrative
Two time points submitted for evaluation; images dated on (b)(6) 2021 are non-contrast only.Images from on (b)(6) 2021 and non-contrast and arterial phases.Unable to confirm migration with the available image sets.There appears to be contrast outside of the graft on the arterial image set dated on (b)(6) 2021.There appear to be an endoleak of indeterminate origin.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.B4: description event updated h6: component code 515 added.H6: conclusion code changed from 4315 to 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.H10: additional manufacturer narrative added: two time points submitted for evaluation; images dated on (b)(6) 2021 are non-contrast only.Images from on (b)(6) 2021 and non-contrast and arterial phases.Unable to confirm migration with the available image sets.There appears to be contrast outside of the graft on the arterial image set dated on (b)(6) 2021.There appear to be an endoleak of indeterminate origin.
Event or Problem Description
On (b)(6) 2015, the patient underwent endovascular treatment of a huge pseudoaneurysm at the proximal anastomosis of an old aorto-bi-iliac graft with erosion of the anterior spine with two different vertebrae.Three gore® excluder® aaa aortic extender endoprostheses were implanted.It was reported that on (b)(6) 2021, the patient presented with back pain.Computed tomography scans dated on (b)(6) 2021, revealed the gore® excluder® aaa aortic extender endoprostheses appear to be creating pressure on the patient¿s anterior lumbar spine and causing erosion into the anterior aspect of it (coded 5000-c: other ¿ explained in file).An additional ct scan taken on (b)(6) 2021 is included in the imaging evaluation that was conducted.This evaluation demonstrated the existence of a type 1b endoleak.Further information regarding reintervention was not provided.

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12323846
• Report Number: 2953161-2021-01086
• Device Sequence Number: 2826343
• Product Code: MIH
• UDI-Device Identifier: 00733132618439
• UDI-Public: 00733132618439
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

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: 01/31/2018
• Device Model Number: PLA360400
• Device Catalogue Number: PLA360400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 93 KG