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

Model Number	RLT351416
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional patient and case information has been requested from the physician.The device remains implanted, and the delivery catheter was discarded at the facility.An analysis of relevant data will be performed in view of supporting the identification of possible causes of the event.
Event or Problem Description
On (b)(6) 2021 the patient underwent treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported that the leading olive tip separated from the catheter in the introducer sheath after implant deployment.
Additional Manufacturer Narrative
H.6.Investigation findings: code 213 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation findings: code 213 - an analysis of relevant data was performed in view of supporting the identification of possible causes of the event.The engineering evaluation stated the following: the device evaluation was performed based on a photo attached to the case as the device was not returned for analysis.The evaluation of this photo showed the following: the leading end of the delivery catheter is separated from the rest of the catheter.The polyimide appears to be separated at approximately the mid-olive.The leading olive is still attached to the separated portion of the polyimide.Based on the findings from this evaluation, the physician¿s observation that the leading end had become completely detached was confirmed.The likely cause for the separated leading end could not be determined with the available information.No further patient or case information will be provided by the physician.H.6.Investigation findings: code 3233 updated to code 213.H.6.Investigation findings: code 3233 updated to code 213.H.6.Investigation conclusions: code 11 updated to code 4315.

• 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: 11996178
• Report Number: 3007284313-2021-01470
• Device Sequence Number: 16947596
• Product Code: MIH
• UDI-Device Identifier: 00733132618484
• UDI-Public: 00733132618484
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/09/2021

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: 06/07/2023
• Device Model Number: RLT351416
• Device Catalogue Number: RLT351416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1