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

Model Number	RLT231214
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medwatch report will capture the type ia endoleak associated with rlt231214/ (b)(4).(b)(4).A review of the manufacturing records for the devices verified that the lots met all pre-release specifications.The devices remain implanted and, therefore, were not available for direct analysis by gore.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to, endoleak and aneurysm enlargement.Additionally, per ifu, key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation, short proximal aortic neck and significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.
Event or Problem Description
On (b)(6) 2019, the patient underwent endovascular treatment of an abdominal aortic aneurysm using two gore® excluder® aaa endoprostheses.On (b)(6) 2020, a follow-up computed tomography (ct) scan reportedly identified a type ia endoleak, and a type ib endoleak on the right (contralateral) side.The cause of the endoleaks is not known, but it was suspected that calcification in the infrarenal neck and iliac arteries may have been a contributing factor.The aneurysm sac measured 4.5cm x 5.1cm on this date.On (b)(6) 2020, a follow-up examination reportedly confirmed the type ia and ib endoleaks.The aneurysm sac measured 5.6cm x 5.2cm on this date.On (b)(6) 2020, the patient underwent a reintervention procedure whereby an aortic extender component was implanted proximally to treat the type ia endoleak.The physician also coil-embolized the right hypogastric artery, and then implanted an iliac extender component distally to treat the type ib endoleak.Both endoleaks were resolved and 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: 11087960
• Report Number: 3007284313-2020-01210
• Device Sequence Number: 11781808
• Product Code: MIH
• UDI-Device Identifier: 00733132622337
• UDI-Public: 00733132622337
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2020

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: 04/23/2022
• Device Model Number: RLT231214
• Device Catalogue Number: RLT231214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR