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

Catalog Number	RLT231416
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional device: (b)(4).It is not known which device appeared to have become compressed, therefore both devices were investigated.A review of the manufacturing records for the devices verified the lots met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), in the pre-treatment planning it states: determine accurate size of anatomy and proper size of trunk-ipsilateral and contralateral endoprostheses (tables 21 and 22) and aortic and iliac extender endoprostheses (tables 23 and 24).Per the trunk-ipsilateral leg endoprosthesis sizing guide, the intended iliac vessel diameter for the rlt23416 device is 12-13.5 mm.Per the contralateral leg endoprosthesis sizing guide the intended iliac vessel diameter for the plc271000 21.5-25 mm.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of a common iliac artery aneurysm with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses.The patient did not have an abdominal aortic aneurysm, and the gore® excluder® iliac branch component was seated entirely in the common iliac artery.A 27 mm contralateral leg component was used as a bridge between the contralateral gate and the iliac branch component.The distal aorta appears to be measuring approximately 20 mm.On (b)(6) 2018 it was recognized that one of the device limbs of the gore® excluder® aaa endoprostheses appeared to have been compressed.On (b)(6) 2018 a reintervention was performed whereby a 14 mm begraft stent was placed within the non-compressed limb and a 12 mm begraft stent was placed on the compressed side.The patient did well following 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: 7629771
• Report Number: 3007284313-2018-00186
• Device Sequence Number: 1432860
• Product Code: MIH
• UDI-Device Identifier: 00733132622382
• UDI-Public: 00733132622382
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/27/2018

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: 11/14/2019
• Device Catalogue Number: RLT231416
• Device Lot Number: 15692950
• 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: 06/22/2018
• Supplement Report FDA Received Date: 06/30/2018
• 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; Required Intervention
• Patient Age: 66 YR