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

Model Number	RLT281214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
It was reported that during a procedure gore® excluder® aaa endoprosthesis (rlt281214/21448982) was advanced over the.035 meier¿ guidewire through the 18fr dryseal sheath.After a full deployment when the excluder® device was taken out, the olive tip remained on the wire at the tip of the sheath.This was an area of acute angle in the iliac artery.A fogarty® balloon was advanced above the olive tip and inflated.It was then pulled back and the olive tip was captured in the dry seal sheath.All of the components were retrieved.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition patient comorbidities: hypertension, benign prostatic hyperplasia, asthma, gerd, hypercholesterolemia, aaa, and colonoscopy addition patient medications: plavix, albuterol, aspirin, atorvastatin, hydrochlorothiazide, lisinopril, metoprolol, and flonase.
Additional Manufacturer Narrative
Addition g4/g5.Addition the device was returned to gore for evaluation.The device evaluation showed the leading end is detached from the rest of the device.The polyimide length of the detached section is approximately 4 cm from the tip of the leading olive and detached at the mid olive.Approximately 4cm of polyimide was not returned for evaluation.The mid-olive is still attached to the polyimide and appears to be intact with no visible defects.A portion 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 end had become completely detached, was confirmed.The polyimide was separated at the mid-olive transition of the catheter.The likely cause for the separated guidewire polyimide lumen 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: 10457830
• Report Number: 3007284313-2020-01047
• Device Sequence Number: 11299481
• Product Code: MIH
• UDI-Device Identifier: 00733132622498
• UDI-Public: 00733132622498
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 02/16/2021

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: 12/11/2022
• Device Model Number: RLT281214
• Device Catalogue Number: RLT281214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/04/2020; 08/04/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 01/29/2021; 02/16/2021
• Patient Sequence Number: 1
• Patient Age: 67 YR