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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gore® excluder® aaa endoprosthesis instructions for use states the following: do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath or catheter.Stop and assess the cause of resistance.Vessel or catheter damage or premature deployment have occurred and may result in potential harms, see adverse events.Do not continue to withdraw the delivery catheter if resistance is felt during removal through the introducer sheath.Forcibly withdrawing the delivery catheter through the introducer sheath when resistance is encountered has resulted in adverse events including catheter breakage or separation resulting in potential harms, see adverse events.
Event or Problem Description
I heard about a complaint about an excluder trunk that happened in (b)(6).Our distributor rep reported that the rlt was prepared according ifu and then introduced to the patient.While trying to place the rlt into position the physician complaint about a resistances he was feeling.The resístanse increased and the device got stuck in the guidewire, so they decided to retrieve the device in tandem with the wire.Outside the patient, in the surgery table, they tried to pull and release the device from the wire but it was not possible, this pulling damaged the device.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.H.6.Results code 2: 213: the device evaluation showed the following: visual examination of the device showed the device was still advanced over the guidewire, the lock pin was dislodged from its seating in the leading olive, and the polyimide had stretched by approximately 16 mm from the leading olive.Engineering attempted to remove the guidewire from the leading olive and was able to do so with no resistance observed.Engineering then attempted to re-insert the guidewire per the instructions for use (ifu) and was able to do so.¿ based on the findings from this evaluation: the physician¿s observation that the device became stuck on the guidewire, could not be confirmed.The physician¿s observation that damage was caused to the device was confirmed ¿ the likely cause for the reported device becoming stuck on the guidewire, could not be determined with the available information.¿ the likely cause for the reported damage to the device, could not be determined with the 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12229946
• Report Number: 3007284313-2021-01524
• Device Sequence Number: 17360702
• Product Code: MIH
• UDI-Device Identifier: 00733132622450
• UDI-Public: 00733132622450
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2022

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: 01/05/2023
• Device Model Number: RLT261414
• Device Catalogue Number: RLT261414
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 11/22/2021; 02/25/2022
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 11/22/2021; 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• 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 Sex: Unknown