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

Catalog Number	RLT261412
Medical Device Problem Codes	Complete Blockage (1094); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier unknown.Manufacturer placeholder provided instead.H3: device remains implanted.H6: investigation in progress.Results will be sent with follow-up report.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) 2023, a patient presenting with an abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.During the procedure, the contralateral leg was unintentionally deployed higher than the long marker at the flow divider by approximately.5 cm.The procedure was completed and the physician decided not to implant a matching limb on the ipsilateral leg.The patient tolerated the procedure.On (b)(6) 2023, the patient presented with occlusion of the trunk ipsilateral leg.An additional contralateral leg was implanted and flow was restored.The patient tolerated the procedure.Patient imaging is not available.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.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.This complaint was initiated based on information received from the field.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.Based on the incident description no allegation of device malfunction, such as stent collapse or structural deformation was indicated with respect to device performance.Therefore the available information does not reasonably suggest a potential malfunction has occurred.The reported device occlusion represents a known complication or adverse event that can occur when using stent-graft endovascular devices and can arise as a result of a multitude of factors, including intra-procedural technical considerations, post-operative treatment regimen and patient-related risk factors.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 device occlusion.
Event or Problem Description
It was reported that on (b)(6) 2023, a patient presenting with an abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.During the procedure, the contralateral leg was unintentionally deployed higher than the long marker at the flow divider by approximately.5 cm.The procedure was completed and the physician decided not to implant a matching limb on the ipsilateral leg.The patient tolerated the procedure.On (b)(6) 2023, the patient presented with occlusion of the trunk ipsilateral leg.An additional contralateral leg was implanted and flow was restored.The patient tolerated the procedure.Reportedly the cause of the occlusion is unknown.It was reported that the contralateral device did not appear as collapsed over to the ipsilateral side nor occluding it.Patient imaging is not available.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17563366
• Report Number: 3007284313-2023-02706
• Device Sequence Number: 15127015
• Product Code: MIH
• UDI-Device Identifier: 00733132622443
• UDI-Public: 00733132622443
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2023

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: 04/16/2026
• Device Catalogue Number: RLT261412
• 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: 08/06/2023
• Supplement Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GORE® EXCLUDER® AAA ENDOPROSTHESIS - PLC161000
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male