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

Catalog Number RLT231218J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to vascular trauma (aortic dissection).(b)(4).

Event Description

On (b)(6) 2017, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses featuring c3® delivery system.After the proximal portion of a trunk-ipsilateral leg component (rlt231218j/16153817) was deployed, the physician decided to reposition the device using a constraining system.The trunk-ipsilateral leg component was then completely deployed, followed by a contralateral leg component being successfully implanted.Intra-procedure imaging was run, revealing a retrograde aortic dissection from the proximal end of the trunk-ipsilateral leg component to the superior mesenteric artery.Further intervention was not performed, and the initial procedure was concluded.It was reported that the vessel diameter of the patient¿s proximal neck ranged from 16.3mm ¿ 16.9mm.Additionally, it was reported by the physician that the patient¿s aorta was fragile and the proximal end of the trunk-ipsilateral leg component may have damaged the vessel wall during repositioning manipulation.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6666143
• MDR Text Key: 78346806
• Report Number: 3007284313-2017-00163
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2020
• Device Catalogue Number: RLT231218J
• Device Lot Number: 16153817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR