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

Catalog Number	PXT261416
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to endoleak.
Event or Problem Description
On (b)(6) 2010, the patient underwent an endovascular procedure with using gore® excluder® aaa endoprostheses for treatment of an abdominal aortic aneurysm.On (b)(6) 2019, follow-up imaging reportedly identified a proximal type i endoleak with no reported aneurysm enlargement.It was reported disease progression caused the aortic neck to dilate and the trunk-ipsilateral leg component to lose apposition of the neck, resulting in the proximal type i endoleak.On (b)(6) 2019, an intervention was performed to treat the endoleak.An aortic extender component was reportedly implanted for improved apposition to the aortic wall.Reportedly, the endoleak was resolved and the patient tolerated the procedure.
Event or Problem Description
On (b)(6) 2019, follow-up imaging reportedly identified a proximal type i endoleak with no reported aneurysm enlargement.It was reported disease progression caused the aortic neck to dilate and the trunk-ipsilateral leg component to lose apposition of the neck, resulting in the proximal type i endoleak.
Additional Manufacturer Narrative
Corrected date of event.Corrected event description.Images were sent to gore for evaluation: images provided are post-implant cta dated on (b)(6) 2019, arterial and delay phases.Length from the left renal to the proximal end of the device appears to measure ~ 20mm.Diameter just distal to the left renal appear to measure ~ 24 mm.Diameters ~ 10 mm distal to the left renal appear to measure ~ 30 mm.Diameters ~ 15 mm distal to the left renal appear to measure ~ 34 mm, flow lumen and thrombus.There does not appear to be wall apposition at the proximal end of the implanted device.Pooling of contrast within the aneurysmal sac is not visualized on the arterial and delay phases.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8293084
• Report Number: 2953161-2019-00009
• Device Sequence Number: 1620057
• Product Code: MIH
• UDI-Device Identifier: 00733132610235
• UDI-Public: 00733132610235
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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: 08/31/2013
• Device Catalogue Number: PXT261416
• Device Lot Number: 8411922
• 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: 01/31/2019
• Supplement Report FDA Received Date: 02/14/2019
• 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: 64 YR
• Patient Weight: 112