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

Catalog Number	PLC161400
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Insufficient Device Problem Information (3190); Separation Problem (4043)
Health Effect - Clinical Codes	Aneurysm (1708); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, the patient underwent endovascular procedure using a gore® excluder® aaa endoprosthesis to treat an abdominal aortic aneurysm.Reportedly, after the gore® dryseal sheath insertion, the end part of the catheter broke off and had to be snared out.No further adverse events have been reported.
Additional Manufacturer Narrative
H.6.Code c19: a review of the manufacturing record for the device verified that the lot met all pre-release specifications.The device remains implanted and is not available for analysis, however, the delivery catheter was sent to gore for evaluation.The investigation is in process.Further information will be provided.Code e2402- was used to explain that the device was implanted, however, the delivery catheter broke off and had to be snared out.Additional information was requested.Code f23- was used to explain the snare procedure.Code a26- was used to cover that insufficient information was provided.Additional information was requested.Code b10- was used to explain that the delivery catheter was provided for analysis.The investigation is in process.Code b20: was used to explain that the device remains implanted, however, the delivery catheter was sent for analysis.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.
Additional Manufacturer Narrative
Additional information: section a: patient's information was added.B5: event description was updated due to the information received from the physician.H.6.Code c19: a review of the manufacturing record for the device verified that the lot met all pre-release specifications.The device remains implanted and is not available for analysis, however, the delivery catheter was sent to gore for evaluation.The investigation is in process.Further information will be provided.Code e2402- was used to explain that the device was implanted, however, the delivery catheter broke off and had to be snared out.Code f23- was used to explain the snare procedure.Code a26- was used to cover that insufficient information was provided.Code b01- was used to explain that the delivery catheter was provided for analysis.The investigation is in process.Code b20: was used to explain that the device remains implanted, however, the delivery catheter was sent for analysis.
Event or Problem Description
On (b)(6) 2023, the patient underwent endovascular procedure using a gore® excluder® aaa endoprosthesis to treat an abdominal aortic aneurysm.Reportedly, after the gore® dryseal sheath insertion, the end part of the catheter broke off and had to be snared out.According to the physician, it is unknown what caused the problem.There was nothing strange about the patient¿s anatomy and there was no resistance felt or any difficulty moving the device.The damage was noted at the tip of the device after the deployment system had been removed.No further adverse events have been reported.The patient tolerated the procedure.
Additional Manufacturer Narrative
H.6.Code c19: a review of the manufacturing record for the device verified that the lot met all pre-release specifications.The device remains implanted and is not available for analysis, however, the delivery catheter was sent to gore for evaluation.The delivery catheter was returned to gore for engineering analysis and the evaluation of the returned device showed the following: the returned device had the catheter leading end (leading olive and polyimide guidewire lumen) separated from the rest of the catheter at the trailing olive.The separated catheter leading end had clean cuts of the polyimide guidewire lumen at the trailing end.There were kinked and flattened sections along the lengths of the guidewire lumens.The guidewire lumen sections near the leading olive bond and separated trailing end are open.The separated guidewire lumen remains bonded to the leading olives.The trailing olive of the catheter were intact and had remnants of the guidewire lumen pebax coating indicating that the guidewire was bonded to the trailing olive.The findings from the evaluation are consistent with the reported complaint of separation of the leading end of the catheter.The cause for the separation of the leading end of the catheter could not be determined with the currently available information.This type of occurrence will continue to be monitored.According to the gore excluder® aaa endoprosthesis instructions for use (ifu), section ¿warnings¿ : when withdrawing the device delivery system through the introducer sheath, verify all catheter components are intact.Catheter leading end separation or breakage and related potential patient harms have occurred.If catheter separation occurs, use best medical judgment to determine the appropriate course of action for the patient.Effective removal of the catheter component has been reported through both surgical (e.G., cut down) and endovascular techniques (e.G., snaring, sheath removal).Code e2402- was used to explain that the device was implanted, however, the delivery catheter broke off and had to be snared out.Code f23- was used to explain the snare procedure.Code a26- was used to cover that insufficient information was provided.Code b01- was used to explain that the delivery catheter was provided for analysis.The investigation is in process.Code b20: was used to explain that the device remains implanted, however, the delivery catheter was sent for analysis.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17495385
• Report Number: 3013164176-2023-01795
• Device Sequence Number: 15267126
• Product Code: MIH
• UDI-Device Identifier: 00733132618729
• UDI-Public: 00733132618729
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2023

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: 05/04/2024
• Device Catalogue Number: PLC161400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 08/10/2023; 10/30/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 08/11/2023; 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Male