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

Catalog Number	RLT231214
Medical Device Problem Codes	Partial Blockage (1065); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019 the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.During the procedure it was noted that the aortic diameter at the level of the trunk-ipsilateral leg component flow divider was, "13mm-14mm." reportedly, it was suspected that post-deployment ballooning of the contralateral gate may have caused the ipsilateral limb to partially collapse.It was reported that, on (b)(6) 2019, thrombus was noted in the ipsilateral limb of the trunk-ipsilateral leg component below the device flow divider.It was also reported that the contralateral leg component located in the patient's right common iliac artery, was occluded.It was reported that, on (b)(6) 2019, a thrombectomy was performed, and the physician deployed two bare metal stents within the trunk-ipsilateral leg and contralateral leg components, creating a new flow divider.The procedure was concluded and no further issues were reported.The patient tolerated the procedure.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: item #plc121000/ lot #16497255/ udi (b)(4).Which is captured in manufacturer report #3013164176-2019-00020.

• 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: 8380262
• Report Number: 3007284313-2019-00055
• Device Sequence Number: 2977700
• Product Code: MIH
• UDI-Device Identifier: 00733132622337
• UDI-Public: 00733132622337
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/18/2019

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: 08/19/2021
• Device Catalogue Number: RLT231214
• Device Lot Number: 18489980
• 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: 02/28/2019
• Supplement Report FDA Received Date: 03/21/2019
• 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: 89 YR