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

Model Number PLC161000

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2023

Event Type  malfunction  

Manufacturer Narrative

Patient weight: asked but unavailable other relevant history, including preexisting medical conditions: asked but unavailable concomitant medical products and therapy dates: asked but unavailable investigation findings: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.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 treatment of an infrarenal abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported that there was an estimated 90 degree bend in the patient's left common iliac artery, and the area was highly calcified.It was reported that a contralateral leg component was advanced and deployed on the patient's left side with no issues.Reportedly, the delivery catheter was successfully removed and the physician opted to extend with an additional contralateral leg component.It was reported that the introducer sheath was advanced with no issues.It was noted that ballooning may have been necessary due to the artery being potentially stenotic.However, there were no reported issues with device advancement, delivery, or deployment.It was reported that there was difficulty managing the left access site due to plaque and bleeding in the cutdown area.It was noted that, after successful deployment of the secondary contralateral leg component, the physician removed the delivery catheter quickly in an attempt to finish the case and maintain the left side.After removal of the delivery catheter, it was observed that the leading olive tip had separated from the delivery catheter and remained within the patient.It was reported that the suspected cause of the leading olive tip separation was the vessel tortuosity.The leading olive tip was retrieved using a snare catheter.Reportedly no portion of the delivery catheter remained in the patient.There were no further reported issues and the procedure was successfully completed.The patient tolerated the procedure.

Manufacturer Narrative

H.6.Investigation findings for testing of actual/suspected device: code c19 - the device evaluation showed that the device was returned with the endoprosthesis deployed off the delivery catheter.There was blood on the returned device delivery catheter.The leading olive had pulled off the polyimide guidewire lumen of the delivery catheter.The leading olive was not returned for evaluation.Leading olive material transfer was seen on the polyamide guidewire lumen of the delivery catheter.The material transfer seen indicates the leading olive had been bonded to the catheter.Based on the findings from this evaluation, the reported observation that the leading olive became separated from the delivery catheter was confirmed.The cause for the separated leading olive could not be determined with the currently available information.H.6.Investigation findings: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d15.

Manufacturer Narrative

H.6.Investigation conclusions: code d1001 added.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16486243
• MDR Text Key: 310724984
• Report Number: 3013164176-2023-01630
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618668
• UDI-Public: 00733132618668
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PLC161000
• Device Catalogue Number: PLC161000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 04/12/2023; 06/05/2023
• Supplement Dates FDA Received: 05/12/2023; 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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
• Patient Age: 82 YR
• Patient Sex: Male