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

Model Number	RLT281218
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, this patient was implanted with a gore® excluder® aaa endoprosthesis trunk-ipsilateral leg component.After deployment, when removing the delivery catheter, the leading olive became separated from the delivery catheter inside the patient's body but remained on the guidewire.The physician was able to retract the guidewire and remove the olive outside of the patient.There was no harm to the patient.
Additional Manufacturer Narrative
Engineering evaluation summary: the device evaluation showed the following: the leading end is detached from the rest of the device.The mid-olive is still attached to the delivery system and appears to be intact with no visible defects.A small partition of the polyimide can be observed at the mid-olive transition.Based on the findings from this evaluation, the physician¿s observation that the leading olive had become separated from the delivery catheter, was confirmed.The separation appears to be a fracture of the polyimide at the mid-olive transition of the catheter.The likely cause for the fracture of the polyimide at the mid-olive transition of the catheter 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
• MDR Report Key: 11309083
• Report Number: 3007284313-2021-01243
• Device Sequence Number: 3865648
• Product Code: MIH
• UDI-Device Identifier: 00733132622511
• UDI-Public: 00733132622511
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 08/17/2022
• Device Model Number: RLT281218
• Device Catalogue Number: RLT281218
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 07/12/2021
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 129