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

Model Number	PLC141000
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: plc20140/ (b)(4), udi: (b)(4) , plc181200/ (b)(4), udi: (b)(4).Pre-treatment: computed tomography (ct) (b)(6) 2018.Maximum abdominal aortic aneurysm diameter: 58mm.Ct dated (b)(6), 2018, maximum abdominal aortic aneurysm diameter: 58mm.Ct dated (b)(6) 2019, maximum abdominal aortic aneurysm diameter: 50mm.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018, a patient underwent treatment of a 58mm abdominal aortic aneurysm with a gore® excluder® conformable aaa endoprostheses.On (b)(6) 2018, images revealed there was a kink in the device.A reintervention was performed and a stent graft with expandable balloon was implanted.The kink was resolved and the patient tolerated the procedure.
Additional Manufacturer Narrative
Addition additional investigation determined which device had the adverse event reported (kink and reintervention) on it.The (gore® excluder® aaa contralateral leg endoprosthesis plc181200 lot # 18262714) has the allegation of deficiency.The plc141000 lot # 18185280, plc201400 lot # 18277803 have no product problem or deficiency caused or contributed to an adverse event/incident for the patient.
Event or Problem Description
It was reported, additional investigation determined ultrasound of the right femoral region confirmed patency post reintervention procedure (a gore® viabahn® vbx balloon expandable endoprosthesis was implanted).While advancing a 0.018 guidewire while utilizing intravascular ultrasound (ivus), a right iliac artery stenosis at the flow divider was identified.The narrowest segment was 6mm and the normal diameter was 13mm.An 8 fr sheath was used, and the area was stented and post dilated with 14mm balloon.Ivus verified remaining mild kinking of the right iliac artery at the flow divider.There was brisk flow shown on angiography.The kinking did not cause obstruction of the vessel lumen.

• 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: 14674735
• Report Number: 3013164176-2022-01400
• Device Sequence Number: 14828513
• Product Code: MIH
• UDI-Device Identifier: 00733132618637
• UDI-Public: 00733132618637
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 10/30/2022

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: 05/29/2021
• Device Model Number: PLC141000
• Device Catalogue Number: PLC141000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 10/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2018
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White