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

Model Number	RMT281416
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Ischemia (1942); Unspecified Gastrointestinal Problem (4491); Aneurysm expansion (4597)
Date of Event	02/04/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
H6-b13: a request was emailed to the study coordinator to clarify the cause of the ischemia, the relationship between the device/procedure and the ischemia, and if patient imaging is available.The answer is pending.H6-b14: the manufacturing records are being reviewed.H6-b20 and h3-other: the device remains implanted in the patient.Therefore a device evaluation could not be performed.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.
Event or Problem Description
It was reported that on (b)(6) 2011, a patient presenting with an abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.On (b)(6) 2014, computed tomography (ct) imaging showed a maximum aortic aneurysm diameter of 72.2 mm.On (b)(6) 2022, the last date when imaging was available, ct imaging showed a maximum aortic aneurysm diameter of 103 mm.On (b)(6) 2022, the patient presented with ischemic colitis.The physician stated that the device or procedure contributed to the condition.No treatment was documented.The patient died due to the same condition on (b)(6) 2022.
Additional Manufacturer Narrative
D10 concomitant medical products: gore® excluder® aaa endoprosthesis (serial number (b)(6), catalog pxc181200).Gore® excluder® aaa endoprosthesis (serial number (b)(6), catalog pxc181000).Cause investigation and conclusion: the incident information was received from a prospective study.The database entries were reviewed and the provided information was captured in sections a through e.Request was emailed to the study coordinator to clarify the cause of the ischemia, the relationship between the device/procedure and the ischemia, and if patient imaging is available.The requests remained unanswered.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause to the reported ischemic colitis.The physician stated that the device or procedure contributed to the condition.No further information was provide to gore.It remains unclear to what extent the product or procedure contributed to the reported ischemic colitis.The gore® excluder® aaa endoprosthesis instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail.The ifu states the following: potential device or procedure-related adverse events adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to: aneurysm enlargement; bowel complications (e.G., ileus, transient ischemia, infarction, necrosis).

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17272906
• Report Number: 3007284313-2023-02603
• Device Sequence Number: 14772636
• Product Code: MIH
• UDI-Device Identifier: 00733132610723
• UDI-Public: 00733132610723
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2023

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: 08/31/2014
• Device Model Number: RMT281416
• Device Catalogue Number: RMT281416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 10/17/2023; 11/23/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 10/17/2023; 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2011
• 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: Death; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male