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

Model Number	PLC161000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
On (b)(6) 2022, the patient was admitted for treatment of an aneurysm rupture and graft repair of a non-gore graft.As reported, the patient was implanted with gore® excluder® aaa endoprostheses.As reported, the gore® excluder® aaa endoprosthesis contralateral leg component was fully deployed.As reported, during catheter withdrawal some resistance was felt.As reported, the leading olive tip had detached from the catheter.As reported, an attempt was made to advance the sheath for retrieval of the olive tip, but this was not successful.As reported, the olive was successfully snared and removed from the patient.The patient tolerated the procedure.As reported, there was a tight bend in the iliac artery where the olive detached.The catheter and olive were saved for return to gore for evaluation.
Additional Manufacturer Narrative
Updated code from d16 to d15 under investigation conclusions.The device evaluation showed the following: the leading end of the catheter (polyimide guidewire lumen) had separated from the catheter body at the trailing olive.The polyimide guidewire lumen had pulled out of the trailing olive bond.There was evidence of gold coating color material from the polyimide guidewire lumen observed inside of the trailing olive indicating that the olive had been bonded to the polyimide guidewire lumen.The end of the guidewire lumen was examined for evidence of a tensile break.The end of the guidewire lumen had a clean cut indicating the guidewire lumen did not break.The leading olive was firmly attached to the polyimide guidewire lumen.No damage was observed to the trailing end of the leading olive.The findings from the evaluation are consistent with the physician¿s observation for leading end of the catheter broken.The likely cause for the broken leading end of the catheter could not be determined with the currently available information.

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15840757
• Report Number: 3013164176-2022-01548
• Device Sequence Number: 6096866
• Product Code: MIH
• UDI-Device Identifier: 00733132618668
• UDI-Public: 00733132618668
• Combination Product (Y/N): N
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2025
• Device Model Number: PLC161000
• Device Catalogue Number: PLC161000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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: Other
• Patient Age: 89 YR
• Patient Sex: Unknown
• Patient Weight: 89 KG