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	No Code Available (3191)
Date of Event	07/16/2018
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
The following was reported to gore: on (b)(6) 2018, the patient presented with an abdominal aortic aneurysm that was intended to be treated with gore® excluder® endoprosthesis.It was stated that the aneurysm was not thrombosed and that the maximum diameter of the aneurysm was 75mm.After the trunk-ipsilateral leg component was positioned and deployed without issue, it was stated that the physician experienced difficulty when advancing the guidewire into the contralateral gate of the trunk-ipsilateral leg component.The device was reported to have been reconstrained and rotated in order to reorient the contralateral gate into a more optimal position.The physician elected to fully deploy the trunk-ipsilateral leg component and brought a snare catheter up and over the aortic bifurcation with the intention of pulling the guidewire into the gate (coded (b)(4)).It was stated that after the guidewire was snared, the trunk-ipsilateral leg component lost the proximal seal and was pulled into the aneurysm sac.The physician elected to explant the trunk-ipsilateral leg component and converted the patient to an open surgical repair of the vasculature.The patient tolerated the procedure.
Additional Manufacturer Narrative
Corrected e2 to yes.

• 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: 7755593
• Report Number: 3007284313-2018-00215
• Device Sequence Number: 13843065
• Product Code: MIH
• UDI-Device Identifier: 00733132622511
• UDI-Public: 00733132622511
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2018

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: 01/31/2021
• Device Catalogue Number: RLT281218
• Device Lot Number: 17729730
• 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: 08/07/2018
• Supplement Report FDA Received Date: 09/10/2018
• 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: Required Intervention
• Patient Age: 84 YR