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

Model Number	PXA280300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the instructions for use (ifu) for the gore® excluder® aaa endoprosthesis; adverse events that may occur include, but are not limited to: endoleak.
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.A gore® aortic extender was placed as the most proximal device to exclude coverage of the trunk ipsilateral leg component.The patient tolerated the procedure.On (b)(6) 2020, follow-up imaging shows what appears to be a proximal type i endoleak.The physician plans to reintervene to place an additional aortic extender component proximally; but has not yet scheduled a date.There was no aneurysm enlargement or device migration reported.The cause of the endoleak is unknown.
Additional Manufacturer Narrative
Images were provided to gore and an evaluation showed the following: images provided are a post-implant, arterial phase only cta.Length from the left lowest renal to the proximal end of the circumferential device appears to measure ~ 16.4 mm.There appears to be a lack of wall apposition within the proximal 15 mm of the implanted aortic extender device.There appears to be a contrast-like density outside of the implanted device, aortic extender, however, contrast cannot be confirmed without a non-contrast ct.H6: code 213- a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Additional Manufacturer Narrative
B6: height: 157cm, bmi 38.17 patient medical history includes but is not limited to: aaa, acid reflux, anemia, anxiety, arthritis, asthma, back problem, chest pain, chronic pain, copd, coronary atherosclerosis, eye problems, graves disease, history of mi, history of tobacco use, hyperlipidemia acquired, hypertensive disorder, hypothroidism following radioiodine, therapy, obesity, sinus bradycardia, syncope, thyroid condition, type ii diabetes mellitus well controlled.D11: patient medications include but are not limited to: acetaminophin, albuterol, albuterol-ipratropim , nebulized inhaler, brimonidine-brinzolamind opthalmic, senna s, irbesartan, levothyroxine, montelukast, multivitamin, nitroquick, sublinqual, omega 3, pantoprazole, lyrica.G4/g5: additional/corrected information.
Event or Problem Description
On (b)(6) 2020, the patient underwent reintervention for a proximal type i endoleak and aneurysm enlargement to approximatley 5cm.A gore® excluder® aortic extender component was placed proximally just below the lowest renal artery and resolved the endoleak.The patient tolerated the procedure.

• Brand Name: GORE EXCLUDER CONFORMABLE AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10210059
• Report Number: 2953161-2020-01000
• Device Sequence Number: 2880244
• Product Code: MIH
• UDI-Device Identifier: 00733132609895
• UDI-Public: 00733132609895
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 07/22/2020

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: No Information
• Device Expiration Date: 08/31/2013
• Device Model Number: PXA280300
• Device Catalogue Number: PXA280300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 06/29/2020; 06/29/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 07/14/2020; 07/22/2020
• 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
• Patient Age: 66 YR