MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	RLT231418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical devices medical devices: pt medications: hydrochlorothiazide, lotrisone, levothyroxine, prilosec, anacin, lisinopril, flomax, norvasc, and lipitor.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2020, the patient was being implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that after five attempts of reconstraining and repositioning the gore® excluder® aaa endoprosthesis (rlt281418/21067318), the physician noticed under fluoroscopy that the lock pin wire had protruded out of the olive tip and appeared to be penetrating the aorta.The physician was ok with the position of the device and decided to fully deploy the device.Fluoroscopy was done after deployment at several angles, there was no evidence of a ruptured aorta or complete/full penetration through the aorta and no contrast outside the aorta.The device was deployed in accurate place and there was no further sequela.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition h6-code 213: the device was returned to gore for evaluation.Per gore engineering a visual inspection of the leading end of the device did not reveal any damages to the olive.Based on the findings from the evaluation, because the device has been deployed, the physician¿s observation that, under fluoroscopy, the lock pin wire had protruded out of the olive tip could not be confirmed.The physician¿s observation that the lock pin wire appeared to be penetrating the aorta could not be confirmed.The likely cause for the reported lock pin becoming dislodged from the leading olive could not be determined with the available information.Addition h6: code 67.Addition according to the gore® excluder® aaa endoprosthesis instructions for use, warning: do not constrain/reopen the trunk device more than two times during a procedure.Device and/or catheter damage may occur.The ifu also states that the proximal aortic neck angulation should be less or equal to 60º.
Event or Problem Description
Reportedly the case was in an angled aortic neck.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9693172
• Report Number: 3007284313-2020-00040
• Device Sequence Number: 19438723
• Product Code: MIH
• UDI-Device Identifier: 00733132622399
• UDI-Public: 00733132622399
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2022
• Device Model Number: RLT231418
• Device Catalogue Number: RLT231418
• Device Lot Number: 21067318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 109