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

Model Number	PLC161200
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The field sales associate (fsa) reported the following: on (b)(6) 2022, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.The patient tolerated the procedure.It was reported that follow up images, (computed tomography dated (b)(6) 2022), revealed both limbs of devices bilaterally were compressed.There was some flow and the patient presented nonsymptomatic.Reportedly during the original procedure, ¿the distal aorta was small¿.On (b)(6) 2022, the physician reintervened and implanted a gore® viabahn® vbx balloon expandable endoprostheses inside each gore® excluder® aaa endoprostheses limb.This opened the compression.The patient tolerated the procedure.Root cause of compression- during the original procedure, ¿the distal aorta was small¿.
Additional Manufacturer Narrative
Addition section b-computed tomography (ct) images were sent to gore imaging services for evaluation.Per the evaluation multiple pre-implant axial images dated (b)(6), 2021, illustrates what appears to be a heavily calcified abdominal aorta with a diameter of 11mm.Post implant axial image dated (b)(6), 2022, illustrates a compressed left ipsilateral limb.Post implant axial image dated (b)(6), 2022, illustrates a compressed right contralateral limb.Centerline reconstruction from ct dated (b)(6), 2022, illustrates a compressed left ipsilateral limb.Centerline reconstruction from ct dated (b)(6), 2022, illustrates a compressed right contralateral limb.Addition 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.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14398279
• Report Number: 3013164176-2022-01374
• Device Sequence Number: 5451294
• Product Code: MIH
• UDI-Device Identifier: 00733132618705
• UDI-Public: 00733132618705
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: 09/06/2024
• Device Model Number: PLC161200
• Device Catalogue Number: PLC161200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male