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

Catalog Number	PLC231000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2018, this patient underwent an endovascular repair for abdominal aortic aneurysm with a left iliac artery aneurysm using a gore® excluder® aaa endoprostheses, a gore® excluder® iliac branch endoprostheses.Reportedly the patient had very tortuous anatomy.It was reported that after the final angiogram, there was sluggish flow on the left side and diminished pulses (1000-e:-other - explained in file).The physician decided to perform a cut down and endarterectomy.There was a dissected flap but the left femoral artery was patent.The next day an angiogram revealed one of the devices had compressed, but it is unknown which one (plc231000/18198471, ceb231210a/18065349, and hgb161007a/18007068).On (b)(6) 2018, the physician reintervened and attempted to use a pta balloon to open all three devices by inflating and dragging the inflated balloon up and down all three devices.The patient¿s blood pressure became unstable and the physician performed an open procedure, a fem-to-fem bypass.The pulses to the foot were better and the patient tolerate the procedure.

• 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: 7854099
• Report Number: 3013164176-2018-00080
• Device Sequence Number: 1338202
• Product Code: MIH
• UDI-Device Identifier: 00733132618576
• UDI-Public: 00733132618576
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 08/10/2018

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: 06/03/2021
• Device Catalogue Number: PLC231000
• Device Lot Number: 18198471
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 68