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

Model Number	PXC201400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: pxc201200/ 10478427 udi (b)(4), pxc181000/ 10542969 udi (b)(4), pxc181200/ 10285587 udi (b)(4), and pxt281412/ 8067688 udi (b)(4).
Event or Problem Description
The following was reported to gore: on (b)(6) 2013, the patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprostheses.It was reported that the patient is being scheduled for a left iliac repair.
Additional Manufacturer Narrative
Addition h6 codes: code 213-the review of the manufacturing paperwork verified that these lots met all pre-release specifications.Addition code 22-the gore® excluder® aaa endoprosthesis instructions for use (ifu) states: patients should be counseled as to the possibility of subsequent reinterventions including catheter-based and open surgical conversion.Addition images were sent to gore imaging services for evaluation.Per the evaluation there is one time-point available for evaluation, post-implantation computed tomography angiography (cta) dated (b)(6), 2021.The aortic diameter just distal to the right renal artery appears to be 23.1mm.It is unclear aortic margins/borders at the level of the renal arteries.Aortic diameter ~8mm distal to the right renal artery appears to be 54.7mm.Aortic diameter 15mm distal to the right renal artery appears to be 67.0mm.The proximal end of the device appears to be ~95.9mm distal to the right renal artery.Cannot confirm device migration with one time-point.Angulation in the proximal abdominal aorta appears to be ~90degrees.Maximum diameter of the aaa appears to be 68.9mm x 100.0mm.Maximum diameter of the left common iliac artery (lci) aneurysm appears to be 68.0mm x 74.9mm.There appears to be lack of distal seal in the distal contralateral leg.Type ib endoleak (type i distal endoleak).Addition: patient weight-89kg, patient comorbidities: previous abdominal aortic aneurysm, anxiety, copd with emphysema, hematuria, hypertension, sciatica, and upper respiratory infection, patient medications: albuterol, aerosol, aspirin, atorvastatin, hydrocodone, and metoprolol.

• 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 WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13028303
• Report Number: 2017233-2021-02617
• Device Sequence Number: 1816690
• Product Code: MIH
• UDI-Device Identifier: 00733132610051
• UDI-Public: 00733132610051
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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: 06/30/2014
• Device Model Number: PXC201400
• Device Catalogue Number: PXC201400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male