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

Catalog Number	RMT281416
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Codes	Aneurysm (1708); Occlusion (1984)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The device will be provided for analysis.Further information will be reported.
Event or Problem Description
On (b)(6) 2018, the patient underwent an endovascular procedure using a gore® excluder® aaa endoprosthesis featuring c3® delivery system to treat an abdominal aortic aneurysm.It was reported that an 18fr dryseal sheath compatible to the main body was used in the femoral artery, which measured 10.8mm in diameter.The device was prepared as requested by ifu.The sheath was positioned in the left common iliac artery under fluoroscopy over an extra stiff guidewire.The gore® excluder® aaa endoprosthesis was advanced to the intended position under fluoroscopy, however, the left renal artery was partially covered.The physician tried to move the device back, however, reportedly, the distal part of the ipsilateral leg prematurely released.The physician decided to remove the device and the sheath together.The patient tolerated the procedure.
Additional Manufacturer Narrative
Based on the engineering evaluation completed on 10/15/2018, the type of the event was changed to product problem/malfunction.The device and the sheath were sent to gore for analysis.The engineering evaluation showed that the distal (trailing) portion of the sleeve was scrunched or pushed proximally (towards the leading end), allowing the distal (trailing) end of the stent beneath to expand outward.The deployment line was unbroken and the stitch line remained fully sewn.The leading end of the introducer sheath was damaged in a way that is consistent with the endoprosthesis being pulled against the leading end of the sheath.Engineering was able to confirm the physician¿s observation that the distal portion of the ipsilateral leg was prematurely released.However, the investigation observations are consistent with the endoprosthesis being pulled against the leading end of the sheath.The likely cause for the observed damage to the returned device is consistent with interaction of the trailing end of the endoprosthesis with the leading end of the sheath during positioning of the trunk-ipsilateral leg endoprosthesis.According to the gore® excluder® aaa endoprosthesis featuring c3® delivery system instructions for use, adverse events that may occur and / or require intervention include, but are not limited to improper component placement.
Event or Problem Description
On (b)(6) 2018, the patient underwent an endovascular procedure using a gore® excluder® aaa endoprosthesis featuring c3® delivery system to treat an abdominal aortic aneurysm.It was reported that an 18fr dryseal sheath compatible to the main body was used in the femoral artery, which measured 10.8mm in diameter.The device was prepared according to the gore® excluder® aaa endoprosthesis instructions for use (ifu).The sheath was positioned in the left common iliac artery under fluoroscopy over an extra stiff guidewire.The gore® excluder® aaa endoprosthesis was drifting and physician tried to move the device back carefully in a way that it wouldn´t cover the renal artery.During the attempt to reposition the device, the device came in contact with the sheath and this end of the device began to open slightly.Because the device had opened slightly, it was no longer possible to remove it through the sheath, so both the sheath and device were removed.The patient tolerated the procedure.

• 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: 7848772
• Report Number: 3007284313-2018-00252
• Device Sequence Number: 1445700
• Product Code: MIH
• UDI-Device Identifier: 00733132610723
• UDI-Public: 00733132610723
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2020
• Device Catalogue Number: RMT281416
• Device Lot Number: 15888377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• 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: 09/05/2018
• Supplement Report FDA Received Date: 10/22/2018
• 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; Other
• Patient Age: 71 YR
• Patient Weight: 71