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

Model Number	PLC181000
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted, so evaluation of the actual device was unable to be completed.Images were provided, and an imaging evaluation was performed.The review of the manufacturing paperwork verified that the lot met all pre-release specifications.The imaging evaluation stated the following: one time-point available for evaluation: post-implantation cta dated (b)(6) 2020.There appears to be contrast outside the contralateral limb in the rci.The contrast outside the implanted device limb appears to communicate with contrast in the distal aneurysmal sac.There appears to be contrast in a low set of lumbar arteries communicating with contrast pooling in the aneurysmal sac.Cannot confirm antegrade or retrograde flow with available imaging.Right common iliac artery diameters appear to range from 16.7mm ¿ 20.1mm.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to, endoleak.
Event or Problem Description
On (b)(6) 2016 the patient underwent endovascular treatment using gore® excluder® aaa endoprostheses.On february 21, 2020 images were received from the physician (post-implantation computed tomography angiography dated (b)(6) 2020) identifying a distal type i endoleak on the contralateral leg component located on the patient's right side.The cause of the endoleak was suspected to be dilation of the patient's iliac artery.On (b)(6) 2020 a reintervention was performed.A gore® excluder® iliac branch component and a gore® viabahn® vbx balloon expandable endoprosthesis were implanted.Reportedly the endoleak was successfully resolved.The patient tolerated the procedure.

• 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: 9838720
• Report Number: 3013164176-2020-00039
• Device Sequence Number: 764562
• Product Code: MIH
• UDI-Device Identifier: 00733132618743
• UDI-Public: 00733132618743
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: 06/30/2018
• Device Model Number: PLC181000
• Device Catalogue Number: PLC181000
• Device Lot Number: 14086502
• 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: 03/17/2020
• 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: Required Intervention
• Patient Age: 82 YR