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

Catalog Number	RMT311413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications include but are not limited to: aspirin, zoloft, digoxin, coreg, amlodapine besylate, nitroglycerine, novolyn, allopurinol, ipratropium albuterol, calcium, mucinex, symbicort, iron, satalol.
Event or Problem Description
On (b)(6) 2012, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis featuring c3® delivery system.The patient tolerated the procedure.On (b)(6) 2017, follow-up imaging determined an endoleak, the aneurysm diameter was reported to measure 6.8 cm.It was unable to determine if the endoleak was a proximal type i or a type ii endoleak.On (b)(6) 2018, follow-up imaging determined an endoleak persisted; the aneurysm diameter was reported to measure 7.3 cm.It was unable to determine if the endoleak was a proximal type i or a type ii endoleak.On (b)(6) 2018, the patient underwent reintervention.Three angiogram's were performed on the patient however the type and source was inconclusive.A gore® excluder® aortic extender component was placed proximally to extend coverage.Final angiography was unable to determined if the endoleak was resolved.The patient tolerated the procedure.
Additional Manufacturer Narrative
Date of event: corrected/additional information.
Additional Manufacturer Narrative
Additional information.

• 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: 7777849
• Report Number: 2017233-2018-00497
• Device Sequence Number: 19271864
• Product Code: MIH
• UDI-Device Identifier: 00733132610747
• UDI-Public: 00733132610747
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2018

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: 02/28/2015
• Device Catalogue Number: RMT311413
• Device Lot Number: 10161416
• 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: 08/13/2018
• Supplement Report FDA Received Date: 08/27/2018; 08/28/2018
• 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: 76 YR
• Patient Weight: 117