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

Model Number	RLT231414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient comorbidities: hypertension (htn), hyperlipidemia (hld), chronic low back pain, spinal stenosis, and history of prostate cancer.Medications: ciclopirox external solution 8 %, sulfamethoxazole-trimethoprim oral tablet 800-160 mg, ketoconazole external cream 2 %, meloxicam oral tablet 15 mg, carvedilol oral tablet 12.5 mg, atorvastatin calcium oral tablet 20 mg, venlafaxine hcl er oral capsule extended release 24 hour 150 mg, amlodipine besylate oral tablet 5 mg, losartan potassium oral tablet 100 mg,and fluticasone propionate nasal suspension 50 mcg/act.Allergies: none indicated.Past medical and surgical: the patient has a past medical history of hypertension, cancer prostate cancer, hyperlipidemia, depression, cardiovascular, disease aaa.Other past medical history includes aaa, spinal stenosis.Hernia repair, aaa repair, knee surgery, prostatectomy, former smoker.(b)(4).Known inherent risk of device - 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, endoprosthesis endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2019 the patient was implanted with the following gore® excluder® aaa endoprostheses for endovascular aneurysm repair treatment of an abdominal aortic aneurysm.Rlt231414 (gore lot/sn: (b)(4)), trunk ipsilateral leg endoprosthesis.Plc141200 (gore lot/sn: (b)(4)) contralateral leg endoprosthesis.As reported by the physician for history of the presented illness, the post-procedure ultrasound surveillance suggested continued residual aneurysm sac expansion and computed tomography angiography (cta) suggested an endoleak was present.It was reported that there was an attempted endoleak repair by interventional radiology conducted in (b)(6) of 2022 from which it was suggested a type i or type iii endoleak was present.The aneurysm sac remained asymptomatic.On (b)(6) 2022 the type iii endoleak was confirmed between the overlap of the gore® excluder® aaa trunk ipsilateral c3 and contralateral leg endoprostheses.As reported, it is unknown if the cause of the endoleak is due to incorrect placement of the contralateral limb resulting in insufficient overlap, or due to endoprosthesis migration.On (b)(6) 2022 reintervention was conducted.The procedure consisted of relining the existing components at the device overlap with a according to the gore® excluder® aaa contralateral leg endoprosthesis (plc141000).Angiography was performed following the procedure and confirmed that there was no remaining endoleak.As reported, there were no procedure related complications and the patient is doing well.No images are available for evaluation.

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13967450
• Report Number: 3007284313-2022-01844
• Device Sequence Number: 17187729
• Product Code: MIH
• UDI-Device Identifier: 00733132622375
• UDI-Public: 00733132622375
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 03/31/2022

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: 12/19/2021
• Device Model Number: RLT231414
• Device Catalogue Number: RLT231414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male