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

Model Number	PXT281414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pxc201000/06042483 udi (b)(4) and pxc201400/05957738 udi (b)(4).Patient comorbidities: aaa, acute mi, acute systolic heart failure, aortic root enlargement, aortic regurgitation, cad, chf, hypertension, kidney stones, mitral regurgitation, nstemi, shingles, and sick snus syndrome.Patient medications: amlodipine, apixaban, aspirin, zetia, lasix, and toprol-xl 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.
Event or Problem Description
On (b)(6) 2008, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that images revealed the patient had a distal type i endoleak (date and modality of images is unknown) in the left common iliac artery.There is aneurysm sac enlargement reported (amount is unknown).The cause for the type i endoleak is unknown.There was a reintervention on (b)(6) 2020.The physician implanted a gore® excluder® contralateral leg endoprostheses bilaterally and extended already implanted device in the right and left common iliac arteries.The end result was successful with no endoleak.The patient tolerated the reintervention procedure.It is unknown which implanted devices had the endoleak, therefore, all implanted devices will be included in this event.
Additional Manufacturer Narrative
Addition g5.

• Brand Name: GORE EXCLUDER 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: 10766871
• Report Number: 2017233-2020-01395
• Device Sequence Number: 3261548
• Product Code: MIH
• UDI-Device Identifier: 00733132610303
• UDI-Public: 00733132610303
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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: 05/31/2011
• Device Model Number: PXT281414
• Device Catalogue Number: PXT281414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 01/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 111