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

Model Number	RLT261414
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
It was reported that the patient presented with an abdominal aortic aneurysm that was treated with gore® excluder® aaa endoprostheses.After advancing the device to the intended position and after deploying the proximal endoprosthesis, it was stated that it appeared difficult to perform the ipsilateral leg deployment as the handle appeared to be blocked.It was necessary to pull the remaining deployment lines accessing the backup deployment hatch.The procedure was completed with favorable results and the patient tolerated the procedure.
Additional Manufacturer Narrative
H10/11: code 10 - the device evaluation showed the following: the constraining mechanism was still attached to the handle, the access hatch and handle covers were removed from the handle.Engineering was able to activate the red safety lock.The black nut guide was approximately ¼ turn from the fully unconstrained position.Engineering attempted to move the black nut guide was unable to do so.The handle screw assembly compression spring had slipped out of its channel in the housing and is off track.Based on the findings from the evaluation, the physician¿s observation that it appeared difficult to perform the ipsilateral leg deployment could not be confirmed but is consistent with being unable to remove the constraining mechanism due to an off track compression spring.The physician¿s observation that the handle appeared to be blocked could not be confirmed.The likely cause for the compression spring being out of its housing and off track could not be determined with the available information.Updated device problem code to 2577.
Additional Manufacturer Narrative
Medwatch #3007284313-2020-01184 was sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch (and supplementals) will be retracted.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: joerg kersten ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10948168
• Report Number: 3007284313-2020-01184
• Device Sequence Number: 19705570
• Product Code: MIH
• UDI-Device Identifier: 00733132622450
• UDI-Public: 00733132622450
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2022

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: 07/07/2023
• Device Model Number: RLT261414
• Device Catalogue Number: RLT261414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 11/04/2020; 11/04/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 05/07/2021; 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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: 79 YR
• Patient Sex: Male