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

Catalog Number	RMT281416
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Migration (4003)
Health Effect - Clinical Codes	Aneurysm (1708); Occlusion (1984)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant medical conditions: hyperlipidemia, coronary artery disease (cad), peripheral vascular disease (pvd), renal cell carcinoma with left nephrectomy, current smoker.Concomitant medical product(s): lisinopril, norvasc, asa, lipitor, prilosec, ntg prn, premarin & xanax.The review of the manufacturing paperwork verified that the lot met all pre-release specifications.Additional devices included on this report are as follows: pxc181400/06753648/(01)00733132610020(17)120430(21)06753648.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: aneurysm enlargement, component migration & occlusion of device or native vessel.
Event or Problem Description
On (b)(6) 2011, the patient underwent endovascular treatment using gore® excluder® aaa endoprostheses.On (b)(6) 2019, the patient had a re-intervention due to graft migration and a loss of seal in the proximal neck.It was also reported that device was near occlusive kinking of the left iliac limb and there was reported perineal aortic enlargement.Distance of the migration is unknown but a ct scan taken (b)(6) 2017 measured the aneurysm sac at 36cm and another ct scan taken (b)(6) 2019 measured the sac at 43mm (7cm growth).The physician reportedly re-lined the previously implanted gore® excluder® aaa endoprosthesis and the patient tolerated the procedure.The patient was seen for a 1 week post op and is reportedly doing well and blood flow through the device is good.On august 31st, 2019 the product surveillance u.S.Regional leader was attending a seminar when the complainant notified her of a possible adverse event.The physician stated he had to reline and previously implanted gore® excluder® aaa endoprosthesis.
Additional Manufacturer Narrative
A4: added pt weight.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9124537
• Report Number: 2017233-2019-00928
• Device Sequence Number: 2333434
• Product Code: MIH
• UDI-Device Identifier: 00733132610723
• UDI-Public: 00733132610723
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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: 07/31/2014
• Device Catalogue Number: RMT281416
• Device Lot Number: 9491822
• 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: 09/26/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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: 77 YR
• Patient Weight: 68