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

Model Number	PLC271400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinical specialist (cs) reported the following: on (b)(6) 2021, this patient underwent an endovascular repair for a right iliac aortic aneurysm with a gore® excluder® iliac branch endoprostheses.The patient tolerated the procedure.It was reported that during follow up images on (b)(6) 2023, there was aneurysm sac enlargement (amount is unknown) and a type iii endoleak (component disconnection).A reintervention was performed to bridge the disconnection between the gore® excluder® aaa contralateral leg endoprosthesis (lot/serial number is unknown) and the gore® excluder® aaa endoprostheses iliac branch component.During the reintervention procedure the physician was using a 18fr sheath so he could advance the delivery catheter and a aptus tourguide 6fr sheath together.He planned to advance collagen plugs into the aneurysm sac with the aptus tourguide sheath.There was no resistance while advancing the delivery catheter or the 6fr sheath.When deploying the gore® excluder® aaa contralateral leg endoprosthesis there was difficulty with the deployment.The last 2cm of the device would not fully deploy.The physician used force to get the deployment complete and the deployment line broke (¿snapped off at the delivery catheter¿).The physician tried to retract the delivery catheter and could not do so since the distal end of the device was not open.While trying to retract the delivery catheter the olive became separated from the delivery catheter.The physician went through the left iliac artery to snare the olive tip and the lunderquist guidewire he was using to snare became stuck around the aortic bifurcation.It is unknown what was preventing the wire from being retracted.The physician chose to do a retroperitoneal cut down.He used occlusion balloons and then clamped the aorta distal and proximal to implanted gore devices and was able to cut the deployment sleeve of the partially deployed contralateral leg endoprosthesis, it deployed.He was also able to remove the olive tip and guidewire.It is unknown what was preventing the guidewire from being able to be retracted.An additional device was implanted to reline the implanted devices.While performing the cut down procedure a pool of blood was noticed on the operating room floor.The gore® dryseal flex introducer sheath valve was not fully inflated and there was a blood leak.A blood transfusion was given during the procedure.The patient tolerated the procedure.
Additional Manufacturer Narrative
Patient medications: xarelto.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.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16806708
• Report Number: 3013164176-2023-01673
• Device Sequence Number: 16595426
• Product Code: MIH
• UDI-Device Identifier: 00733132618606
• UDI-Public: 00733132618606
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

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: 03/13/2025
• Device Model Number: PLC271400
• Device Catalogue Number: PLC271400
• 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: 03/28/2023
• Initial Report FDA Received Date: 04/25/2023
• Date Device Manufactured: 03/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 177 KG