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

Model Number	RLT231418
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to gore that a gore® excluder® aaa endoprosthesis (rlt231418), which was intended to be used for an endovascular aneurysm repair (evar), would not advance through the gore® dryseal flex introducer sheath (dsf1633).An alternative gore® excluder® aaa endoprosthesis (rlt231416) was used instead and the case was completed successfully.
Additional Manufacturer Narrative
No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The device evaluation concluded on april 25, 2022 showed the following: visual examination of the device showed the lock pin was dislodged from the olive.Engineering attempted to insert the device through a 16 fr introducer sheath per ifu but was unable to do so.Based on the findings from this evaluation, the physician¿s observation that the device would not advance through the introducer sheath was confirmed.The likely cause for the device unable to would advance in the introducer sheath was unable to be determined with the available information.The likely cause for the dislodged lock pin is forcibly inserting the device into the introducer sheath.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), trunk-ipsilateral leg endoprosthesis positioning warning states: 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 patient harms, see adverse events.
Additional Manufacturer Narrative
H6: added health effect - impact code 2199 - no health consequences or impact.Added type of investigation codes 4111 and 4119.Added investigation findings code 213 - no device problem found.Investigation findings code 3243 refer to the type of investigation code 10, with investigation conclusions codes 61 and 22.Investigation findings code 213 refers to the type of investigation code 3331, with investigation conclusions code 4315.Code 4111 and 4119: multiple attempts have been made to acquire additional information to classify any possible specific device problem, such as reason for the advancement issue, patient details, and details of usage of the introducer sheath.No additional information has been provided.

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14315992
• Report Number: 3007284313-2022-01895
• Device Sequence Number: 5000693
• Product Code: MIH
• UDI-Device Identifier: 00733132622399
• UDI-Public: 00733132622399
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2022

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: 12/08/2023
• Device Model Number: RLT231418
• Device Catalogue Number: RLT231418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown