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

Catalog Number	RMT231418
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	06/05/2018
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) 2012, the patient presented with an abdominal aortic aneurysm that was treated with the implantation of gore® excluder® aaa endoprostheses.On (b)(6) 2018, follow-up ct and ultrasound imaging showed device occlusion of the right leg of the gore® excluder® aaa endoprostheses.It was stated that the occlusion was successfully treated with the implantation of an additional device on (b)(6) 2018.
Additional Manufacturer Narrative
Updated date of event and event.Imaging evaluation: post-implantation ct images, dated (b)(6), 2018 were provided to gore for evaluation.The evaluation showed the following: the coronal reconstruction illustrates that the right ipsilateral limb is occluded.The axial image illustrates that the right ipsilateral limb is occluded.The axial image illustrates that the right external iliac is patent.
Event or Problem Description
The following was reported to gore: on (b)(6), 2012, the patient presented with an abdominal aortic aneurysm that was treated with the implantation of gore® excluder® aaa endoprostheses.On (b)(6), 2018, follow-up ct and ultrasound imaging showed device occlusion of the right leg of the gore® excluder® aaa endoprostheses.The cause of the occlusion of the device is unknown.The occlusion was successfully treated with the implantation of 4 expandable covered stents on (b)(6), 2018.
Additional Manufacturer Narrative
Code 4112: refer to field b6 for the results of the imaging evaluation.

• 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: 7756046
• Report Number: 2017233-2018-00490
• Device Sequence Number: 13892541
• Product Code: MIH
• UDI-Device Identifier: 00733132610570
• UDI-Public: 00733132610570
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2018

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: 08/31/2015
• Device Catalogue Number: RMT231418
• Device Lot Number: 10667537
• 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: 08/07/2018
• Supplement Report FDA Received Date: 11/13/2018; 11/23/2018
• 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: PXC141200/10497888; PXC141200/10497888
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 65