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

Model Number	RLT351414
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
On (b)(6) 2013, the patient was treated for an abdominal aortic aneurysm.The physician implanted a gore® excluder® aaa endoprosthesis featuring c3® delivery system and two gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On an unknown date, it was discovered that the gore® excluder® aaa endoprosthesis featuring c3® delivery system had migrated distally due to dilatation.Plans were made to reintervene on (b)(6) 2023, two gore® viabahn® vbx balloon expandable endoprosthesis(s) (vbx device) were intended as snorkel devices during treatment of an aortic aneurysm.The vbxs were to be implanted as part of a procedure to extend proximally with a cook device.One vbx device was stationed in the mesenteric artery inside the introducer sheath (manufacturer unknown) and another vbx device was stationed in the renal artery inside the introducer sheath (manufacturer unknown) and were being staged for deployment.However, while advancing a cook thoracic device the aneurysm was dissected and the blood pressure dropped.The physicians were unable to get the bleeding under control and the patient expired.There was no allegation against the gore device in relation to the patient death.It was due to the aneurysm rupture caused by attempted implant of the cook device.
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis featuring c3® delivery system instructions for use, adverse events with may occur and/or require intervention including, but not limited to, component migration h6: type of investigation code b21 updated to code b14 with completion of phr review.H6: investigation findings: code c21 updated to code c19 as a result of phr review.H6: investigation conclusions: code d16 updated to code d12 and d15.

• 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 SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17059113
• Report Number: 2017233-2023-03978
• Device Sequence Number: 17404441
• Product Code: MIH
• UDI-Device Identifier: 00733132618477
• UDI-Public: 00733132618477
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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: 10/31/2015
• Device Model Number: RLT351414
• Device Catalogue Number: RLT351414
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2012
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female