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

Model Number	RLT281416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient comorbidities: copd, hypertension, and afib.Patient medications: albuterol, amlodipine, apixaban, calcium citrate, vitamin d3, duloxetine, famotidine, fenofibrate micronized, ferrous gluconate, fluticasone, gabapentin, levothyroxine, metoprolol, omeprazole, rosuvastatin, solifenacin, sotalol, umeclidinium, valsartan, and zinc oxide.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.
Event or Problem Description
On (b)(6) 2019, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.Reportedly, during the original procedure two gore® viabahn® vbx balloon expandable endoprostheses were used for a chimney technique in the renal arteries (lot/serial number is unknown and not available).It was reported that computed tomography images dated (b)(6) 2020, revealed the patient had a proximal type i endoleak.It is unknown if there is aneurysm sac enlargement (previous ct images are not available for comparison).The cause for the type i endoleak is unknown, but the physician stated "it could be possible gutters that lead to possible migration".On (b)(6) 2020, the physician reintervened and implanted a gore® excluder® aortic extender endoprosthesis proximally and bilaterally extended proximally both viabahn® vbx balloon expandable endoprostheses.The endoleak was resolved at the end of the case.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: 10622132
• Report Number: 3007284313-2020-01090
• Device Sequence Number: 3054950
• Product Code: MIH
• UDI-Device Identifier: 00733132622542
• UDI-Public: 00733132622542
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: No Information
• Device Expiration Date: 05/08/2022
• Device Model Number: RLT281416
• Device Catalogue Number: RLT281416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 01/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 93