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

Catalog Number	RLT231418
Medical Device Problem Codes	Partial Blockage (1065); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Refer to field for the results of the imaging evaluation.
Event or Problem Description
The following was reported to gore: on (b)(6) 2018, the patient presented with an abdominal aortic aneurysm and an aneurysm in the left internal iliac artery that were successfully treated with gore® excluder® aaa and gore® excluder® iliac branch endoprostheses (ibe).It was stated that no issues occurred during the implant procedure and that the final imaging was very satisfying.On (b)(6) 2018, the patient presented very strong pain in the stomach region to the emergency department of the hospital.Imaging revealed a collapsed trunk-ipsilateral leg endoprosthesis, caused by thrombus that developed between the aorta and the device.According to the physician the patient stopped using the antiplatelet drug that he should have taken.During a reintervention procedure the thrombus was removed and the device ballooned with favorable results.The patient tolerated the procedure.

• 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: 7741730
• Report Number: 3007284313-2018-00214
• Device Sequence Number: 11114040
• Product Code: MIH
• UDI-Device Identifier: 00733132622399
• UDI-Public: 00733132622399
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2021
• Device Catalogue Number: RLT231418
• Device Lot Number: 17884966
• 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: 08/02/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 111