MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number DSF2233

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 11/05/2021

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2021, a patient underwent endovascular treatment of a thoracic aortic aneurism using gore® tag® conformable thoracic stent graft with active control system (ctagac), najuta stent graft and gore® dryseal flex introducer sheaths with debranch of a brachiocephalic artery, left common carotid artery and left subclavian artery.Dsf2233 was used for a right access.An final angiography for the access vessel revealed a dissection at the right external iliac artery and an occlusion at the right internal iliac artery.An additional bare metal stent (smart 10 mm x 6 cm) was implanted to the part of the dissection.The patient tolerated the procedure.Reportedly, it was unclear whether the dissection and the occlusion occurred in the dsf2233 or the najuta.The right internal iliac artery had severe thrombotic stenosis and seemed to have very little forward blood flow before the treatment.The diameter of the external iliac artery was around 7.1 mm to 10.2 mm.

Manufacturer Narrative

(b)(4).

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12931170
• MDR Text Key: 283496164
• Report Number: 3007284313-2021-01686
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630073
• UDI-Public: 00733132630073
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSF2233
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/17/2021
• 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: 84 YR
• Patient Sex: Male