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

Catalog Number	PLA280300
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that these lots met all pre-release specifications.(b)(4).Also was involved in reportable endoleak: pla320400/13759266, udi# (b)(4) and rlt261412/14368902, udi# (b)(4).Images were sent to gore for analysis and two time-points were available for evaluation: post-implantation cta dated (b)(6) 2017 and intra-operative angiogram dated (b)(6) 2018.The images showed that the proximal aortic extender appears to be ~4.5cm in length.The device overlap of the distal end of the proximal aortic extender (pla320400/13759266) and the proximal portion of the 2nd aortic extender (pla280300/ 14437681) appears to be ~6.7mm.The 2nd aortic extender appears to be 3.3cm in length.The device overlap of the distal end of the 2nd aortic extender and the proximal portion of the excluder® device appears to be ~4.7mm.Contrast can be visualized outside the implanted devices at this distal area of device overlap (pla320400 and pla280300) and at this distal area of device overlap (pla280300 and rlt261412).Intra-operative angiogram imaging appears to show a resolved type iii endoleak with an additional 2 aortic extenders implanted.According to the gore® excluder® aaa endoprosthesis instructions for use, the maximum recommended extension with each aortic extender component is approximately one-half of the extender length inside (1.6 cm or 2.2 cm) and one-half, outside (1.6 cm or 2.2 cm), or proximal to the trunk or aortic extender host component.The proximal three and distal one markers are visible relative to host device and anatomy pre and post-deployment.According to the gore® excluder® aaa endoprosthesis instructions for use, additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Gore recommends that the gore® excluder® aaa endoprosthesis diameter be at least 2 mm larger than the aortic inner diameter (10-21% oversizing) and 1 mm larger than the iliac inner diameter (7-25% oversizing).According to the sizing guidelines for the pla280300 device the aortic inner diameter range is 24 - 26mm.For the pla320400 device the aortic inner diameter range is 27 - 29mm.Reportedly the maximum aortic neck diameter in the landing zone was 24.5 mm.According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to improper component placement, endoleak and aneurysm enlargement.Please note that the proximal type i endoleak and reintervention were covered in medwatch# 3007284313-2016-00199, reported on october 12, 2016.
Event or Problem Description
On (b)(6) 2015, the patient underwent treatment of an abdominal aortic aneurysm and common iliac artery aneurysm with several gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses.Pre-treatment computed tomography angiography (cta) showed that the maximum diameter of the aortic aneurysm/lesion was 43.5mm.Reportedly the maximum aortic neck diameter in the landing zone was 24.5 mm.At the end of the procedure a proximal type i endoleak was identified but left untreated.On (b)(6) 2016, the patient underwent a reintervention procedure whereby two additional gore® excluder® aortic extenders were implanted to treat the proximal type i endoleak.A final angiogram showed resolution of the endoleak.The patient tolerated the procedure.The computed tomography angiography (cta) showed that the maximum diameter of the aortic aneurysm/lesion was 43.5mm (this information was covered by the event# (b)(4), medwatch# 3007284313-2016-00199, reported on october 12, 2016).On (b)(6) 2016, follow-up cta determined that the maximum diameter of aortic aneurysm/lesion was 44mm.It was reported that on (b)(6) 2017, a type iii endoleak was identified due to the disconnection between the aortic components implanted in 2016.On (b)(6) 2017, follow-up cta determined that the maximum diameter of aortic aneurysm/lesion was 49mm.On (b)(6) 2018, the patient underwent the endovascular procedure and two additional aortic components were implanted.No further adverse events have been reported.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8075424
• Report Number: 2953161-2018-00098
• Device Sequence Number: 13886399
• Product Code: MIH
• UDI-Device Identifier: 00733132618781
• UDI-Public: 00733132618781
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2018

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: 10/31/2018
• Device Catalogue Number: PLA280300
• Device Lot Number: 14437681
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 130