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

Model Number	RMT231414
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2011, the patient was treated for an abdominal aortic aneurysm.A gore® excluder® aaa endoprosthesis and 3 cuffs were implanted, and the patient tolerated the procedure.On (b)(6) 2020, the patient presented stable with a ruptured aneurysm, and was treated for a type 1a endoleak.The patient had not been seen in follow up since the index procedure.Four gore® excluder® aaa endoprostheses were implanted, along with six aptus helix endostaples.The patient was awake during the procedure, and tolerated it well.
Additional Manufacturer Narrative
Brand name - corrected to aortic excluder aaa endoprosthesis (c3).
Additional Manufacturer Narrative
H10/11: narrative/corrected data - additional information was provided by the fsa.He stated that that the previously implanted excluder was several cm distal to the renal arteries.The proximal neck at the time of the rupture was very short and angled, less than 8mm long.The physician hoped to get the patient through the immediate danger by adding cuffs and staples.The patient was doing well as of 5/13.The aneurysm had shrunk 0.5cm on ultrasound.Device code 1: 2993 - additional information from fsa.Code 2993 added.Code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications code 22 ¿ according to the gore® excluder® aaa endoprosthesis featuring c3® delivery system instructions for use, adverse events with may occur and/or require intervention including, but not limited to, endoleak.

• 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: 10061262
• Report Number: 2017233-2020-00361
• Device Sequence Number: 14352478
• Product Code: MIH
• UDI-Device Identifier: 00733132610556
• UDI-Public: 00733132610556
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2020

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: 07/31/2014
• Device Model Number: RMT231414
• Device Catalogue Number: RMT231414
• Device Lot Number: 9486333
• 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; Not provided
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 05/18/2020; 06/11/2020
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 64