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

Catalog Number	RLT231416
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019 the patient underwent endovascular repair of a right iliac artery aneurysm using gore® excluder® aaa endoprostheses.It was reported that the patient had a normalized aorta, and that the infrarenal aorta was angled (degree of angulation unknown).Reportedly, due to the angulation of the patient's anatomy, the contralateral leg component was placed approximately 3mm above the flow divider of the trunk-ipsilateral leg component.As a result, it was noted that the contralateral leg component was, "slightly compressed".The patient was heparinized during the procedure.It was reported that on (b)(6) 2019 computerized tomography scans identified thrombus in the proximal end of the ipsilateral limb at the level of the flow divider.Reportedly, there was minimal perfusion through the limb.It was reported that on (b)(6) 2019 a thrombectomy was performed.Reportedly the ipsilateral limb was relined, and the physician placed two bare metal stents within the trunk-ipsilateral leg and contralateral leg components, creating a new flow divider.The procedure was concluded.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #plc271200/lot #18282861/ udi #(b)(4) which is captured in manufacturer report #3013164176-2019-00021.
Additional Manufacturer Narrative
Age at time of event corrected.

• 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: 8394658
• Report Number: 3007284313-2019-00058
• Device Sequence Number: 2887118
• Product Code: MIH
• UDI-Device Identifier: 00733132622382
• UDI-Public: 00733132622382
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/25/2019

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: 12/03/2021
• Device Catalogue Number: RLT231416
• Device Lot Number: 19958179
• 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; Not provided
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 03/19/2019; 04/25/2019
• 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: 61 YR