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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications include metamucil, propranolol, losartan, loped, vitamin b, glucosamine, and calcium.Please see summary below for imaging evaluation findings.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Imaging evaluation summary: ct images dated (b)(6) 2017 and (b)(6) 2018 were received by gore from the facility and an imaging evaluation was performed.On both sets of images, there appeared to be poor proximal wall apposition.There also appeared to be contrast outside of the implanted device, indicative of an endoleak (origin unknown).There appeared to be aneurysm enlargement between the two time points from 68.0 x 65.2 mm to 74.7 x 69.6 mm in diameter.Per the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2013, the patient was implanted with a gore® excluder® aaa endoprosthesis to treat an abdominal aortic aneurysm.On (b)(6) 2017, a follow-up computed tomography (ct) scan reportedly revealed a suspected proximal type i endoleak.On (b)(6) 2018, a follow-up ct scan reported showed the same suspected type i endoleak contributing to aneurysm enlargement.On (b)(6) 2018, the patient underwent a re-intervention procedure whereby an excluder® aortic extender component was implanted to treat the type i endoleak.An intra-operative angiogram reportedly showed the endoleak was not completely resolved.The physician then implanted a palmaz stent proximally, and the endoleak was resolved.The patient tolerated the procedure.
Additional Manufacturer Narrative
Please note correction to date of event: (b)(6) 2017.

• 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: 8038833
• Report Number: 2017233-2018-00661
• Device Sequence Number: 11059734
• Product Code: MIH
• UDI-Device Identifier: 00733132610570
• UDI-Public: 00733132610570
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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: 04/30/2016
• Device Catalogue Number: RMT231418
• Device Lot Number: 11518766
• 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: 11/05/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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: 88 YR
• Patient Weight: 66