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

Catalog Number	RMT261418
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: additional device: pxc141400 lot # 10918955, (b)(4).It is not known which device if either were involved in this event, therefore both are being investigated.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2013 a patient underwent treatment of a 70 mm abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.On (b)(6) 2013 the aneurysm measured 52 mm.On (b)(6) 2016 the aneurysm measured 45 mm.On (b)(6) 2018 the patient presented with a left groin swelling.Ultrasound revealed a large left iliac artery aneurysm.On (b)(6) 2018 the patient underwent emergency open repair of the expanding aneurysm with a 6 mm dacron graft.On (b)(6) 2018 the subject had a cardiac arrest secondary to septic shock.The family declined resuscitation.On (b)(6) 2018 the subject expired.
Additional Manufacturer Narrative
Results code 1: 213: a review of the manufacturing records for the devices verified the lots met all pre-release specifications.Results code 2: 213 a review of the sterilization records for the devices verified the lots met all pre-release sterilization specifications.Upon receiving additional information, the event is no longer considered a reportable event, and is being retracted.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2013 a patient underwent treatment of a 70mm abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.On (b)(6) 2013 the aneurysm measured 52mm.On (b)(6) 2016 the aneurysm measured 45mm.On (b)(6) 2018 the patient presented with a left groin swelling.Ultrasound revealed a large left iliac artery aneurysm.This aneurysm was pre-existing and not in the treatment zone of the gore devices.On (b)(6) 2018 the patient underwent emergency open repair of the expanding aneurysm with a 6mm dacron graft.On (b)(6) 2018 the subject had a cardiac arrest secondary to septic shock.The family declined resuscitation.On (b)(6) 2018 the subject expired.

• 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: 7699413
• Report Number: 3007284313-2018-00210
• Device Sequence Number: 1451754
• Product Code: MIH
• UDI-Device Identifier: 00733132610655
• UDI-Public: 00733132610655
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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: 08/31/2015
• Device Catalogue Number: RMT261418
• Device Lot Number: 10670454
• 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: 07/18/2018
• Supplement Report FDA Received Date: 08/10/2018
• 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; Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 55