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

Catalog Number	RLT261214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to endoleak and reoperation.
Event or Problem Description
On (b)(6) 2017, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported computed tomography images (date unknown), revealed there is a proximal type i endoleak, there is aneurysm sac enlargement (amount is unknown).Patient progress report notes dated (b)(6) 2018, stated under the patients assessment that the patient was treated for aaa in 2017, aneurysm size continues to increase (amount is unknown), two ct scans were performed and there is a possible type ii endoleak from a retrograde filling of the ima in the sac.On (b)(6) 2018, there was a reintervention, the physician coiled the internal mesenteric artery (ima) and there was a balloon angioplasty of the proximal and distal portions of the stents to reinforce ceiling.The patient tolerated the reintervention.
Additional Manufacturer Narrative
Concomitant medical products: patient medications: aspirin, metoprolol, prilosec, vitamin d3, myrbetriq, synthroid, tamsulosin hcl, avodart, milk of magnesia, vitamin c, vitamin e.
Additional Manufacturer Narrative
Method code.

• 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: 7781638
• Report Number: 3007284313-2018-00232
• Device Sequence Number: 13843052
• Product Code: MIH
• UDI-Device Identifier: 00733132622412
• UDI-Public: 00733132622412
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2018

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: 03/19/2020
• Device Catalogue Number: RLT261214
• Device Lot Number: 16115790
• 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: 08/14/2018
• Supplement Report FDA Received Date: 08/14/2018; 09/05/2018
• 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: 87 YR
• Patient Weight: 92