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

Model Number	RMT311415
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Ruptured Aneurysm (4436)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2013, this patient underwent endovascular treatment for an abdominal aortic aneurysm measured 51.2mm and was implanted with gore® excluder® aaa endoprostheses.The patient tolerated the initial procedure.On an unknown date in (b)(6) 2022, the abdominal aortic aneurysm rupture was reported.On an unknown date in (b)(6) 2022, the patient expired.The follow up images were not provided.No adverse events or complications were reported.No additional treatments were performed.The cause of rupture is unknown.The date and the cause of death is unknown.
Additional Manufacturer Narrative
Code c20: a review of the manufacturing record for the device is going to be conducted.The investigation is in process.Further information will be provided.Also were used: pxc121200/ 11714497 udi# (b)(4).Pxc121400/ 9910480 udi# (b)(4).A review of the manufacturing record for the pxc121200/11714497 and pxc121400/9910480 verified the lots met all pre-release specifications.The cause of rupture is unknown.The date and the cause of death is unknown.Additional information was requested.Patient's race: other, mix race "pardo¿.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Additional Manufacturer Narrative
Additional information: b2: outcome; death, (b)(6) 2022 b3: event date b5: event description h1: type of reportable event: death the cause of death is aneurysm rupture, cardiac arrest and hypovolemic shock.The cause of rupture is unknown.As the date of the aneurysm rupture is unknown, the date of death- (b)(6), 2022 will be used as an event date.H.6.Code c20: a review of the manufacturing record for the device is going to be conducted.The investigation is in process.Further information will be provided.
Event or Problem Description
On (b)(6), 2013, this patient underwent endovascular treatment for an abdominal aortic aneurysm measured 51.2mm and was implanted with gore® excluder® aaa endoprostheses.The patient tolerated the initial procedure.On an unknown date in 2022, the abdominal aortic aneurysm rupture was reported.On (b)(6), 2022, the patient expired.The cause of death is aneurysm rupture, cardiac arrest and hypovolemic shock.The follow up images were not provided.No adverse events or complications were reported.No additional treatments were performed.The cause of rupture is unknown.Additional information was requested but was not available.
Additional Manufacturer Narrative
B5: the event description was updated.H6: code c19- a review of the manufacturing records for the devices verified the lots met all pre-release specifications.Also were used: pxc121200/ (b)(6) udi# (b)(4) and pxc121400/ (b)(6) udi# (b)(4).The cause of rupture is unknown.The additional information was requested, however, they don´t have any information about the patient or the aneurysm enlargement after the implant procedure in 2013.They only have the echocardiogram that seems normal.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to aneurysm rupture and death.
Event or Problem Description
It was received from the site that they don´t have any information about the patient or the aneurysm enlargement after the implant procedure in 2013.They only have the echocardiogram that seems normal.
Additional Manufacturer Narrative
Due to the information provided from the physician that the aortic rupture and death were not related with gore devices implanted, this event is no longer considered reportable.The gore device (gore excluder aaa endoprosthesis ) is located in the abdominal aorta and the rupture occurred in the thoracic aorta.This report was sent as a retraction.
Event or Problem Description
The physician reported that the aortic rupture and death were not related with gore devices implanted.The gore device (gore excluder aaa endoprosthesis) is located in the abdominal aorta and the rupture occurred in the thoracic aorta.

• 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
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16368680
• Report Number: 2017233-2023-03716
• Device Sequence Number: 15268599
• Product Code: MIH
• UDI-Device Identifier: 00733132610754
• UDI-Public: 00733132610754
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/17/2023

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: 09/30/2015
• Device Model Number: RMT311415
• Device Catalogue Number: RMT311415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 02/14/2023; 02/20/2023; 03/14/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 02/14/2023; 02/23/2023; 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Death
• Patient Sex: Male
• Patient Weight: 74 KG