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

Model Number	PXT281418
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802)
Date of Event	01/04/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
A review of the manufacturing records for the devices verified the lots met all pre-release specifications.The devices remain implanted and are not available for analysis.Additional information was requested from the hospital; however, it is not available.Also was involved pxc141400/ 8841727 udi# (b)(4).According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include but are not limited to aneurysm rupture and death.
Event or Problem Description
On (b)(6) 2012, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 87mm in diameter and was implanted with gore® excluder® aaa endoprostheses.The trunk ipsilateral leg component was successfully deployed with the contralateral gate on the right side and extended with placement of a contralateral leg component.Control angiography determined a distal type i endoleak in the right common iliac artery (rcia) and additional angioplasty was performed with a coda balloon catheter to resolve the endoleak.It was reported that the maximum diameter of the aortic aneurysm/lesion was decreased in size from 82mm from (b)(6) 2012 till 63mm on ct dated (b)(6) 2018.No more ct images were provided later due to the pandemic situation.Reportedly, on (b)(6) 2021, the patient was admitted at a (b)(6) hospital in (b)(6) with an abdominal pain, vomit and evacuating.A ct scan was performed and detected an aneurysm bleeding.According to the information provided from the site, the probable aneurysm rupture was determined.On (b)(6) 2021, the patient expired.According to the site, the event related to the aortic device or procedure.Additional information was requested from the hospital; however, it is not available.
Additional Manufacturer Narrative
Additional information: b5: event description.Also was involved (b)(4), udi# (b)(4).A review of the manufacturing record for this device verified the lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2021, the patient expired.The death certificate stated that the cause of death was hypovolemic shock, (b)(6).

• 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: 11167631
• Report Number: 2953161-2021-01038
• Device Sequence Number: 11658004
• Product Code: MIH
• UDI-Device Identifier: 00733132610327
• UDI-Public: 00733132610327
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 01/22/2021

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: 03/31/2014
• Device Model Number: PXT281418
• Device Catalogue Number: PXT281418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 01/22/2021
• 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: Death; Hospitalization; Other
• Patient Weight: 53