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

Model Number	PXA230300
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown which device is associated with the type i endoleak.Therefore both devices will be listed.Device lot #8327030, catalog #pxa230300, udi# (b)(4).Device lot #8441124, catalog # pxa230300, udi# (b)(4).The review of the manufacturing paperwork verified that the lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu) regarding use of the aortic extender endoprosthesis, potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, aneurysm enlargement, and endoleak.Furthermore, users are made aware of the risks associated with endoleaks in the ifu, and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.
Event or Problem Description
Following was reported to gore.On (b)(6) 2011, a patient underwent a treatment of dissection of the descending aorta with gore® excluder® aaa endoprosthesis and gore® tag® thoracic endoprosthesis.Two aortic extender component (pxa230300) were placed followed by a tag (tgt2815).The procedure was completed without any issues.The patient tolerated the procedure.On (b)(6) 2016, a follow up image revealed the aneurysm diameter was 50mm.On an unknown date, a follow up image revealed distal type i endoleak at the distal end of one of the two aortic extender endoprosthesis (exact location is unknown), and the aneurysm diameter measured to be 55mm.On (b)(6) 2020, a reintervention was performed to treat the endoleak.A tgm343415 was placed at the distal side of one of the two aortic extender endoprosthesis, to right above the celiac artery.Final angiography revealed no endoleak, and the procedure was completed.The patient tolerated the procedure.

• 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: 9770999
• Report Number: 2953161-2020-00005
• Device Sequence Number: 2574610
• Product Code: MIH
• UDI-Device Identifier: 00733132609871
• UDI-Public: 00733132609871
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/14/2020

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: Health Professional
• Device Expiration Date: 08/31/2013
• Device Model Number: PXA230300
• Device Catalogue Number: PXA230300
• Device Lot Number: 8327030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2020
• 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; Required Intervention
• Patient Age: 75 YR