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

Model Number	PXT231218
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pxl161207/ 03605153 udi (b)(4) and pxc201400/ 03840960 udi (b)(4).Patient medications: tylenol, eliquis, atorvastatin, chlorthalidone, clarinex, dutasteride-tamsulosin, fluticasone, glucosamine, lisinopril, metoprolol, multivitamin, nitroglycerine, pantoprazole, miralax, and ticagrelor.
Event or Problem Description
On (b)(6) 2005, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that the patient had a proximal type i endoleak and the graft migrated distally (date and modality of images is unknown, amount of migration is unknown) and the right implanted contralateral leg endoprosthesis had migrated proximally into the aneurysm sac (amount of migration is unknown).There is aneurysm sac enlargement (approximately 26-30mm).A reintervention occurred on (b)(6) 2021, a cook fenestrated graft was utilized and pulled up the excluder endoprosthesis.The right hypogastric artery was embolized and an additional contralateral leg endoprosthesis was implanted to extend into the right external iliac artery.A contralateral leg endoprosthesis was implanted in each iliac artery to extend both sides of the implanted endoprosthesis.It is unknown which of implanted contralateral leg endoprosthesis devices had migrated.The endoleak was resolved and the patient tolerated the procedure.
Additional Manufacturer Narrative
Updated h6: code 213 - no device problem found.A review of the manufacturing records indicated the lot met 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: endoleaks, aneurysm enlargement, and device migration.

• 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: 11646108
• Report Number: 2953161-2021-01059
• Device Sequence Number: 3049235
• Product Code: MIH
• UDI-Device Identifier: 00733132610129
• UDI-Public: 00733132610129
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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: 06/30/2008
• Device Model Number: PXT231218
• Device Catalogue Number: PXT231218
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 09/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 91