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

Model Number	PLC201200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications include tamsulosin, atorvastatin, diltiazem, stiolto respimat, osteo bi flex, and a multivitamin.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted and, therefore, was not available for direct analysis by gore.It should be noted the gore® excluder® aaa endoprosthesis instructions for use states ¿adverse events that may occur and / or require intervention include, but are not limited to, aneurysm enlargement.".
Event or Problem Description
On (b)(6) 2018, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.On or around (b)(6) 2021, a follow-up computed tomography scan reportedly identified aneurysmal disease progression distal to the contralateral limb and into the internal iliac artery on the left side.On (b)(6) 2021, the patient underwent a re-intervention procedure whereby a gore® excluder® iliac branch endoprosthesis and a gore® viabahn® vbx balloon expandable endoprosthesis were implanted as treatment.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: 11484165
• Report Number: 3013164176-2021-01131
• Device Sequence Number: 3835137
• Product Code: MIH
• UDI-Device Identifier: 00733132618682
• UDI-Public: 00733132618682
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: Health Professional
• Device Expiration Date: 08/06/2021
• Device Model Number: PLC201200
• Device Catalogue Number: PLC201200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 82