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

Model Number	PLC141200
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medical history includes but is not limited to: aaa, hypert,ension, diverticulitis, gi bleen, coronary artery stent placement, left knee prosthetic join infection, left and right knee arthroplasty patient medications include but are not limited to: aspirin, ezetirribe, atenolol, crestor, fosinopril sodium, vitamin b complex, probiotic, super b complex, krill oil, ub.Images were provided to gore for evaluation.The results of the evaluation will be provided in a supplemental medwatch submission.
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 5.3cm x 4.9cm and was implanted with gore® excluder® conformable aaa endoprostheses and the inferior mesenteric artery was embolized with penumbra ruby coils.The patient tolerated the procedure.On (b)(6) 2021, the patient underwent follow-up computed tomography imaging which determined a kink and compression of the contralateral leg component in the right iliac artery.On (b)(6) 2022, the patient underwent reintervention two gore® viabahn® vbx balloon expandable endoprostheses were implanted on both sides.Atlas kissing balloons were used to post dilate both sides to 14mm, intravascular ultrasound (ivus) performed at this time looked great.It was noted that the aorta at the level of the bifurcation was appx 11mm and near circumferentially calcified.The patient was not symptomatic denying any claudication symptoms or any leg problems.
Additional Manufacturer Narrative
H6: code 213- a review of the manufacturing records for the device verified that the lot(s) met all pre-release specifications.H6: code 50: the instructions for use (ifu) states the following: key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation, short proximal aortic neck and significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.The us clinical studies quantify significant thrombus as thrombus = 2 mm in thickness and / or = 25% of the vessel circumference in the intended seal zone of the aortic neck.Irregular calcium and / or plaque may compromise the fixation and sealing of the implantation sites.Imaging was provided to gore for evaluation and showed the following: two time-points were available for evaluation: pre-implantation cta dated (b)(6) 2021 and post-implantation cta dated (b)(6) 2021.Pre-implantation cta images appear to show: the aortic diameter at the distal waist (narrowest part of aorta between lesion and aortic bifurcation) appears to be ~12mm, in calcium.There appears to be calcium in the proximal rci.Rci diameters appear to range from ~9.1mm ¿ 10.0mm.Post-implantation cta images appear to show: images appear to show calcium at the distal waist to the aortic bifurcation for at least 15mm ¿ 18mm.Comparison axial images from both time points appear to show: pre-implant images appear to show circumferential calcium in the distal aorta.The contralateral leg appears to be compressed at the level of the calcium.Pre-implant - diameter at the distal waist appears to be 12.0mm, in calcium.Post-implant ¿ diameter at the same level appears to be 14.8mm, in calcium.
Additional Manufacturer Narrative
An engineering evaluation was performed plc141200 device only and showed the following: the device evaluation was performed based on what was reported to gore and the imaging evaluation attached to the event as the device was not returned for analysis.The imaging evaluation reported that the contralateral leg appears to be compressed at the level where circumferential calcium was in the distal aorta.Based on the imaging evaluation, the physician¿s observation for a kink and compression of the contralateral leg component in the right iliac artery was confirmed.No defects on the device were noted from the imaging evaluation.The cause for the reported kink and compression of the device could not be determined with the available information.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13536161
• Report Number: 3013164176-2022-01299
• Device Sequence Number: 17159542
• Product Code: MIH
• UDI-Device Identifier: 00733132618675
• UDI-Public: 00733132618675
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2024
• Device Model Number: PLC141200
• Device Catalogue Number: PLC141200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 01/27/2022; 01/27/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/15/2022; 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male