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

Catalog Number	RLT261216
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
The following was reported to gore: on (b)(6) 2018 the patient presented with an abdominal aortic aneurysm that was treated with the implantation of gore® excluder® aaa endoprosthesis.It was stated that it was not possible to cannulate the contralateral gate of the trunk-ipsilateral leg endoprosthesis, because it appeared collapsed or twisted.It was necessary to convert the patient to an aorto-uni-iliac procedure and to perform a fem-fem bypass.
Additional Manufacturer Narrative
Updated patient info.Updated event description.Updated conclusion code 1.
Event or Problem Description
The following was reported to gore: on (b)(6) 2018 the patient presented with an abdominal aortic aneurysm that was treated with the implantation of gore® excluder® aaa endoprosthesis.A trunk-ipsilateral leg component was implanted and it was stated that after the deployment was performed the proximal end of the contralateral gate appeared constrained and would not allow passage of a guidewire.The distal end of the contralateral gate was reported to be open.According to the physician, the proximal end of the gate appeared ¿twisted or collapsed¿.It was reported there were no anatomical restrictions that caused or contributed to the device remaining partially constrained and the exact cause of the constrained or ¿twisted or collapsed¿ gate is reportedly unknown.Several attempts to access the contralateral gate were reportedly unsuccessful.It was reported that no blood flow was seen going through the contralateral gate creating an unintentional aorto-uni-iliac (aui) device.It was further reported that a femoral-femoral bypass was performed.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: 7780026
• Report Number: 3007284313-2018-00229
• Device Sequence Number: 19222710
• Product Code: MIH
• UDI-Device Identifier: 00733132622429
• UDI-Public: 00733132622429
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2021
• Device Catalogue Number: RLT261216
• Device Lot Number: 17934330
• Was Device Available for Evaluation?: No
• 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: 08/14/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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: Required Intervention
• Patient Age: 80 YR