MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	RLT261218
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical devices: atient medications include but are no limited to: glucotrol, coumadin, topral, protonix, norvasc, valsite neoral.According to the instructions for use (ifu) for the gore® excluder® aaa endoprosthesis; adverse events that may occur include, but are not limited to: endoleak.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular treatment for an isolated right common iliac artery aneurysm and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system and gore® excluder® iliac branch endoprostheses.The patient tolerated the procedure.On (b)(6) 2020, follow up imaging determined compression of the ipsilateral limb on the left side and an unknown endoleak.No aneurysm enlargement was reported.On (b)(6) 2020, the patient underwent reintervention and an additional contralateral leg component and a gore® viabahn® vbx balloon expandable endoprosthesis were implanted to reline the ipsilateral leg of the trunk component.Intra-procedure imaging determined the endoleak was a type ii originating from a patent inferior mesenteric artery due to retrograde flow from the superior mesenteric artery; and a couple lumbar arteries.At the conclusion of the procedure the endoleak persisted.The patient tolerated the procedure and will be monitored by the physician.
Additional Manufacturer Narrative
H6: code 4117: images were provided to gore and an evaluation was performed.One time-point was available for evaluation, computed tomography dated (b)(6) 2020 which showed the following: there appears to be contrast outside the implanted devices.Contrast pooling appears to wrap around the patient¿s left side.Comparison axial imaging including non-contrast and arterial contrast series appears to show: there appears to be contrast in a lumbar artery at the level of the implanted device.There appears to be contrast pooling in the left side of the aneurysmal sac.More distally, there appears to be contrast pooling in the anterior, left and posterior sac.There appears to be contrast in another set of lumbar arteries.The contralateral gate appears to be on the left side of patient, but the device crosses over into the rci.There appears to be a ~10cm contralateral limb implanted just distal to the contralateral gate.There appears to be another contralateral ¿bridging¿ device implanted with a ~3cm device overlap.There appears to be 13 markers on the contralateral side of the device extending into the rci/rei/rii.( 2 contralateral limbs = 8 markers, ibe markers, internal component = 2 markers).The ipsilateral limb appears to wrap around the contralateral limbs.The device appears to be compressed due to limb competition.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9703443
• Report Number: 3007284313-2020-00046
• Device Sequence Number: 11189807
• Product Code: MIH
• UDI-Device Identifier: 00733132622436
• UDI-Public: 00733132622436
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2022
• Device Model Number: RLT261218
• Device Catalogue Number: RLT261218
• Device Lot Number: 20888119
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/02/2020
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 87