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

Model Number	RLT351418
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was reported to gore: on (b)(6) 2021, a patient was undergoing treatment of an abdominal aortic aneurysm with a gore® excluder® aaa endoprosthesis featuring c3® delivery system.The devices for insertion were prepped as instructed per ifu.A gore® dryseal flex sheath was advanced and placed juxta renally.While advancing the trunk-ipsilateral leg component over a 0.035" wire with a back up meier wire (boston scientific), a little resistance was felt during advancement of the device but advancement to the renals was accomplished.While manipulating, the sheath and device slipped into the aaa sac.Forward pressure was applied to the device, but the device didn't move forward as much as expected and resistance was high.A plan was made to withdraw the device, insert the dilator and advance the sheath again above the renals in order to facilitate the device positioning, but it was not possible to move the device forward or back.While trying to manipulate, the resistance increased and the device became stuck.Having another device available, it was decided to remove the whole system with the wire together in tandem.After the system and wire were removed from the patient an attempt was made to pull out the wire out of the catheter but it was not successful.Without.Another gore® excluder® aaa endoprosthesis featuring c3® delivery system and new wire was utilized to complete the case.The patient tolerated the procedure with no consequence related to this event.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records verified the lot met pre-release specifications.

• 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
• MDR Report Key: 11335309
• Report Number: 3007284313-2021-01254
• Device Sequence Number: 2671844
• Product Code: MIH
• UDI-Device Identifier: 00733132618491
• UDI-Public: 00733132618491
• 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
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: 01/09/2022
• Device Model Number: RLT351418
• Device Catalogue Number: RLT351418
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 02/19/2021
• Patient Sequence Number: 1