MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL VER 3.0); INTRODUCER, CATHETER

Catalog Number DSL2228J

Device Problem No Apparent Adverse Event (3189)

Patient Problem Aortic Dissection (2491)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device could not be conducted as lot number of the device was not available.According to the instructions for use (ifu) of the gore® dryseal sheath with hydrophilic coating, adverse events that may occur and / or require intervention include, but are not limited to vascular trauma (dissection).

Event Description

This report captures the abdominal aortic dissection: on (b)(6) 2018, the patient underwent endovascular repair of a pseudoaneurysm that had been formed around distal anastomosis of a surgical graft in the aortic arch.A 22-fr gore® dryseal sheath with hydrophilic coating (dsl2228j/unknown lot number) was advanced from the right side and positioned distal to the inferior mesenteric artery.A delivery catheter for conformable gore® tag® thoracic endoprosthesis was then advanced through the sheath and deployed with its proximal end positioned inside the surgical graft.Upon withdrawal of the sheath, dissections were formed in two different locations: one was the retrograde abdominal aortic dissection originating from the abdominal bifurcation to the proximal abdominal aortic neck while the other was a localized dissection in the right external iliac artery.It was reported that vessel diameter of the right external iliac artery around the dissection site was 7.5mm.An intervention was performed whereby gore® excluder® aaa endoprosthesis, aortic extender components were implanted in the abdominal aorta to repair the dissection.However, a wait-and-watch approach was taken to the right external iliac artery dissection.The patient tolerated the procedure.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL VER 3.0)
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: yutaka uchiya ; 1500 n. 4th street; 9285263030
• MDR Report Key: 7668818
• MDR Text Key: 113388280
• Report Number: 3007284313-2018-00197
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121234
• 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: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DSL2228J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 80 YR