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

Catalog Number	PLC181400
Medical Device Problem Codes	Malposition of Device (2616); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Death
Event or Problem Description
The fsa reported the following to gore: on (b)(6) 2024, the patient underwent an endovascular index procedure to treat a ruptured aneurysm utilizing the gore® excluder® aaa endoprostheses (trunk ipsilateral, iliac extender, contralateral leg, and aortic extender) it was reported that after the physician deployed the main body, the gate was cannulated and the wire position was confirmed with a pigtail catheter.The fsa left the room to grab a different limb and the wire position was lost and pushed back up without confirming again with a pigtail.The fsa was unaware of the repositioning of the wire.The contralateral limb was then deployed outside of the gate.This lead to the procedure being converted to an aui with fem-fem bypass.The aui was unplanned.The patient tolerated the procedure.The fsa received a call and was notified that the patient passed away over the weekend.It is unknown what caused/contributed to the death of the patient.
Additional Manufacturer Narrative
As it is unknown which device is directly implicated in this death event, the following devices will also be included in this report: catalog #pll161207/ serial (b)(6)/ udi (b)(4).Catalog #plc181400/ serial(b)(6)/ udi (b)(4).Catalog #pla230300/ serial (b)(6)/ udi (b)(4).According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention include death.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
Upon additional review, is was determined that these devices had no impact on the reported death event.Therefore, they should no longer be included in this report.The devices are as follows: catalog #pll161207/ serial # (b)(6)/ udi # (b)(4).Catalog #rlt231412/ serial # (b)(6)/ udi # (b)(4).Catalog #pla230300/ serial # (b)(6)/ udi # (b)(4).Added d4, g3/g4, contact office - manufacturing site, h1/h2, h4, h6.Corrected d4: from: catalog number:rlt231412.Expiration date:05-jun-2027.Serial number:(b)(6).Unique identifier (udi): #(b)(4)/ to: catalog number: plc181400.Expiration date: 27-jan-2027.Serial number:(b)(6).Unique identifier (udi): #(b)(4)/ corrected section g: contact office - manufacturing site: from: site facility name: medical silicon valley b/p.Site address line: 132470 n.North valley parkway.Site us city: phoenix.Site us state : arizona.Site us zip code : 85085.Site country: united states.To: site facility name: medical phoenix 2 b/p.Site address line: 2890 de la cruz blvd.Site us city: santa clara.Site us state : california.Site us zip code : 95050.Site country: united states.Corrected h4: from: device manufacture date: 06-jun-2024.To: device manufacture date: 29-jan-2024.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd; santa clara CA 95050
• Manufacturer Contact: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20241535
• Report Number: 3007284313-2024-03487
• Device Sequence Number: 8516868
• Product Code: MIH
• UDI-Device Identifier: 00733132618699
• UDI-Public: 00733132618699
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/14/2024

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 Catalogue Number: PLC181400
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 10/21/2024; 10/22/2024; 11/14/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/21/2024; 10/22/2024; 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2024
• 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
• Patient Age: 36 YR
• Patient Sex: Male