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

Model Number	PXC141400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #rmt261418/ serial #(b)(4)/ udi #(b)(4).Concomitant medical products and therapy dates: crestor 10mg, aspirin 325mg, plavix 75mg, cardizem 240mg.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, endoleak and aneurysm enlargement.
Event or Problem Description
On an unknown date in 2014 the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.The aneurysm reportedly measured 5.5cm.On (b)(6) 2020 the field sales associate was made aware of aneurysm growth.The aneurysm reportedly measured 6.9cm.Reportedly there was no evidence of an endoleak.On (b)(6) 2020 the patient underwent reintervention to treat the aneurysm enlargement.An aortic extender component and two additional contralateral leg components were used to reline the original device system.The physician reportedly suspected that the aneurysm enlargement may be due to endotension.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
B4: event description added: date of procedure updated.
Event or Problem Description
On (b)(6) 2014, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.

• 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: 10699787
• Report Number: 3013164176-2020-01059
• Device Sequence Number: 3934177
• Product Code: MIH
• UDI-Device Identifier: 00733132609963
• UDI-Public: 00733132609963
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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: 07/31/2016
• Device Model Number: PXC141400
• Device Catalogue Number: PXC141400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10/11 FOR LIST OF MEDICATIONS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 111