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

Catalog Number	RLT281218
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical devices: patient medications include but are not limited to: metapropril tartrate, aspirin, simvastatin.The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoprosthesis: incomplete component deployment, occlusion of native vessel.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2018, this patient underwent endovascular treatment for an abdominal aortic aneurysm and right common iliac artery aneurysm with gore® excluder® aaa endoprosthesis featuring c3® delivery system; and gore® excluder® iliac branch endoprostheses.It was reported that when the prepping the iliac branch component for use, the physician had a great deal of difficulty when removing the protective packaging sheath from the device.After multiple attempts, the physican gave it a ¿hard¿ pull and the sheath came off.The device was examined for any damage and found to be fit for use.The device was then advanced up and over the bifurcation for deployment when it was noticed that wire access had been lost.The physician withdrew the undeployed device from the patient to regain wire acess and at this time noticed that the deployment line seemed loose and the graft seemed to have been pushed forward onto the leading olive.The physican chose to set this device aside and another iliac branch component was implanted.The physician then advanced and deployed the trunk ipsilateral leg component, but was able to cannulate the contralateral gate.After multiple unsuccessful attempts to cannulate the gate the physician performed an aorto uni iliac and a femoral bypass.The patient tolerated the procedure and is doing well.

• 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: 7954043
• Report Number: 3007284313-2018-00285
• Device Sequence Number: 1526148
• Product Code: MIH
• UDI-Device Identifier: 00733132622511
• UDI-Public: 00733132622511
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2018

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: 03/20/2021
• Device Catalogue Number: RLT281218
• Device Lot Number: 17921130
• 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: 10/10/2018
• 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
• Patient Weight: 78