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

Catalog Number PLC231400

Device Problems Premature Activation (1484); Difficult to Remove (1528); Use of Device Problem (1670); Difficult to Advance (2920); Insufficient Information (3190)

Patient Problems Calcium Deposits/Calcification (1758); Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

H.6.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted, however, the delivery catheter will be provided for analysis.Further information will be provided.Images were requested but are not available.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 Description

On (b)(6) 2023, the patient underwent endovascular procedure using gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.The gore® dryseal flex introducer sheath (dsf1433/unknown) was used for access.Reportedly, the plc231400/ (b)(6) was added into a bridge pll161407 into the right iliac artery but the resistance was felt after plc came out of the sheath.Reportedly, the 14fr sheath was not placed up in the bridge limb.On fluoroscopy, it was noticed that the plc231400 had pre-deployed about 1cm.The cause of the plc231400 unintentional deployment remains unknown.The surgeon tried to move the device into the sheath but was unable to.Reportedly, when the physician pulled the device into the sheath, the olive tip pulled into the proximal end of the redeployed limb.They ended up landing the plc231400 in the aorta at the bottom of the bridge and accordioning the 23mm limb into the aaa sac and landing about the internal and external iliac arteries as planned.Then the physician joined the bridge and plc231400 with another limb.There were no adverse effects to the patient and the completion run looked good.The device had a complete deployment.Reportedly, the olive tip was intact after deployment.The pre-ct scan of the right external iliac artery determined a c-shaped calcium area.The delivery catheter will be provided for analysis.Images are not available.

Manufacturer Narrative

Code e- 2402 was used to cover the device unintentional pre-deployment.However, there were no adverse effects to the patient and the completion run looked good.Code f-15 was used to cover that the plc231400 had pre-deployed about 1cm.However, there were no adverse effects to the patient and the completion run looked good.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted, however, the delivery catheter was provided for analysis.The evaluation of the returned device showed that the returned deployment catheter was intact with the leading olive and leading end of the catheter bonded to the trailing olive.The deployment line was not returned in the histology kit.No damage was observed along the length of the catheter from the trailing olive to the catheter hub.During the evaluation, a bend was observed in the polyimide guidewire lumen near the trailing olive.The gore® excluder® aaa endoprosthesis instructions for use (ifu) contains the following warnings: do not advance the device outside of the sheath while tracking it into position.Catheter breakage or premature deployment have occurred and may result in potential patient harms.Do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage or premature deployment have occurred and may result in potential patient harms.Do not attempt to withdraw any undeployed endoprosthesis through the introducer sheath.The sheath and catheter must be removed together.Catheter breakage or separation or premature deployment have occurred and may result in potential patient harms.This evaluation was not able to confirm a cause of the reported pre-deployment with the currently available information.However, the reported advancement outside of the sheath may have contributed to the event.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include but are not limited to unintentional / premature component deployment.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Key anatomic elements that may affect successful exclusion of the aneurysm include significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.Ilio-femoral access vessel size and morphology (minimal thrombus, calcium and / or tortuosity) should be compatible with vascular access techniques.Images were requested but are not available.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18097879
• MDR Text Key: 328656566
• Report Number: 3013164176-2023-01890
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618583
• UDI-Public: 00733132618583
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PLC231400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1