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

Catalog Number	PLC121200
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2011, this patient underwent endovascular repair of a large right iliac artery aneurysm using a gore® excluder® aaa endoprosthesis.On (b)(6) 2018, the patient presented with shortness of breath.Computed tomography was performed which revealed that the entire right iliac artery was now aneurysmal, post repair in 2011.On (b)(6) 2018, a reintervention occurred whereby treatment of the enlarged right iliac artery aneurysm was performed.As the right iliac artery was fully aneurysmal, there was no room to add an extension to the previously implanted device.The physician wanted to spare the right hypogastric artery using a gore excluder iliac branch device, however this was determined not to be a viable option.Therefore two gore® excluder® aaa endoprosthesis contralateral leg components were implanted in the right iliac artery, and the hypogastric artery was intentionally covered.The patient tolerated the procedure.
Additional Manufacturer Narrative
H10/11: additional manufacturer narrative/corrected data.B2: outcomes attributed to this event.G4: date received by manufacturer.
Additional Manufacturer Narrative
H10/11: additional manufacturer narrative/corrected data.B4: date of this report.

• 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: 7778396
• Report Number: 3013164176-2018-00075
• Device Sequence Number: 19281134
• Product Code: MIH
• UDI-Device Identifier: 00733132618712
• UDI-Public: 00733132618712
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/12/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2021
• Device Catalogue Number: PLC121200
• Device Lot Number: 17933216
• 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: 08/13/2018
• Supplement Report FDA Received Date: 08/20/2018; 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(6) 2018: PLC121400/17890351; PLC121400/17890351
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 75 YR