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

Model Number	PLC141400
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following information has been requested but to date has not been received: medications, and comorbidities.(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 an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".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) 2021, the patient was admitted for endovascular aortic repair of an abdominal aortic aneurysm.As reported, a gore® excluder® aaa endoprosthesis (stent graft contralateral leg) was prepped for use in the procedure, inserted, and positioned within the patient.As reported, the physician unscrewed the deployment knob and attempted to pull the deployment line but it was reportedly stuck.The device was removed from the patient and set aside.Another device was obtained and used to complete the procedure.As reported, there were no adverse events, and the patient tolerated the procedure.As reported, there were no anatomical constraints observed.
Additional Manufacturer Narrative
H6: code c19, no device problem found: a review of manufacturing records verified that the lot involved in this event met all pre-release specifications.H6: c16, manufacturing process problem identified: the device engineering evaluation showed the following: blood residue was observed on the device and in the catheter, indicating that it was inserted in the patient.The deployment knob had been unscrewed from the catheter.The deployment line was intact and undamaged through the stitching of the sleeve.The two slip knots on the deployment line loop had the deployment line end pulled through it, creating a knot which prevented the sleeve stitches from unlacing.The findings from the evaluation are consistent with the physician¿s observation.Capa request or141837 was opened for this event.However, capa101628 addressed this type of event.The returned device was manufactured prior to the implemented corrective actions of capa101628.The cause for the inability to deploy the device was the deployment line was pulled through the slip knots on the deployment line loop creating a knot that prevented the sleeve from unlacing.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 an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".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.G3/g4.Date received by manufacturer: 04-oct-2022 h3.Device evaluated by manufacturer updated to, ¿yes¿ h6.Code c21, results pending completion of investigation, replaced with findings h6.Code d16, conclusion not yet available, replaced with final conclusions.

• 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: 15280003
• Report Number: 3013164176-2022-01475
• Device Sequence Number: 16761276
• Product Code: MIH
• UDI-Device Identifier: 00733132618651
• UDI-Public: 00733132618651
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/05/2022

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: 08/08/2022
• Device Model Number: PLC141400
• Device Catalogue Number: PLC141400
• 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: 07/16/2021
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10/H11
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male