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

Model Number RLT281416

Device Problem Difficult to Open or Close (2921)

Patient Problem Aneurysm (1708)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The following was reported to gore: on (b)(6) 2020, the patient underwent endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis featuring c3® delivery system.The device was advanced from femoral artery to the target lesion.When the physician pulled the initial deployment line, the trunk-ipsilateral leg component didn't fully open.The constraining mechanism didn't work, when the physician tried to constrain the proximal end.Therefore, the physician retracted the delivery catheter.After dilation with coda balloon, the trunk-ipsilateral leg component fully opened.However, it moved distally.Therefore, an aortic extender component was placed in the proximal part of the trunk-ipsilateral leg component.The patient tolerant the procedure.

Manufacturer Narrative

H6: code 213 : a review of the manufacturing records indicated the lot met all pre-release specifications.(b)(4), was initiated due to a device having an incorrectly tucked deployment line.The investigation showed that the device with the nonconformance was rejected and rework was performed for the remainder of devices in scope of this event.As a result, all product was dispositioned as accept.Based on the nature of the complaint and the investigation of (b)(4), there is no indication of a relationship between this ncr and the reported complaint.H6: code 3233 ¿ three movies received for evaluation.· no name, date or demographics on movie images provided.(b)(6) 2020 is on the side of the images however, this may not be the date of image acquisition.· movie #1 appears to show an undeployed device.· movie #2 appears to show a partially deployed device.Movie #2 angiogram projection provided does not confirm the proximal end of the partially deployed device is located at the target landing zone.Movie #3 appears to show the device to be fully open.Movie #3 angiogram projection appears to demonstrate a steep aortic angulation near the proximal end of the first implanted device.Movie #3 also appears to show an aortic extender device deployed at the proximal end of the first implanted device.Movie #3 contrast appears to flow through the implanted devices.The device remains implanted, evaluation based on event description and movies is in progress.

Manufacturer Narrative

Update b5: describe event or problem.H6: code 213 ¿ the device remains implanted, engineer evaluation is as below.The device instructions for use (ifu) state: for trunk-ipsilateral let endoprosthesis and aortic extender endoprosthesis: proximal aortic neck angulation = 60º.The device evaluation was performed based on what was reported to gore and videos attached to the event as the device was not returned for analysis.Without a physical sample to evaluate, the physician¿s observation that when the initial deployment line was pulled the trunk-ipsilateral leg component didn¿t fully open, could not be confirmed.The observation that the constraining mechanism didn¿t work, could not be confirmed.Additionally, the likely cause for the trunk-ipsilateral leg component moving distally could not be confirmed.The likely cause for the reported observation that the trunk-ipsilateral leg component didn¿t fully open when the initial deployment line was pulled could not be determined with the available information.The likely cause for the reported observation that the constraining mechanism didn¿t work could not be determined with the available information.

Event Description

The following was reported to gore: on (b)(6), 2020, the patient underwent endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis featuring c3® delivery system.The aortic neck angle of the patient was around 70 degree.The device was advanced from femoral artery to the target lesion.When the physician pulled the initial deployment line, the trunk-ipsilateral leg component didn't fully open.The constraining mechanism didn't work, when the physician tried to constrain the proximal end.Therefore, the physician retracted the delivery catheter.After dilation with coda balloon, the trunk-ipsilateral leg component fully opened.However, it moved distally.Therefore, an aortic extender component was placed in the proximal part of the trunk-ipsilateral leg component.The patient tolerant the procedure.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10715920
• MDR Text Key: 212505913
• Report Number: 2017233-2020-01376
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622542
• UDI-Public: 00733132622542
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2023
• Device Model Number: RLT281416
• Device Catalogue Number: RLT281416
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 09/24/2020; 09/24/2020
• Supplement Dates FDA Received: 12/01/2020; 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 75