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

Catalog Number DSL2428J

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Aortic Dissection (2491)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.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).(b)(4).

Event Description

On (b)(6) 2016, the patient underwent endovascular repair of a distal aortic arch aneurysm using conformable gore® tag® thoracic endoprostheses.Prior to the endoprostheses being implanted, a right axillo-left common carotid-left axillary artery bypass procedure was performed to maintain blood flow to the branch vessels of the aortic arch, and the left subclavian artery was embolized.The physician tried to advance a 24-fr gore® dryseal sheath with hydrophilic coating (dsl2428j/15314532) from the left side, but resistance was met.The physician removed the sheath, advanced it again from the right side and deployed two endoprostheses distal to the brachiocephalic artery.Upon withdrawal of the sheath, it was revealed that aortic dissection was formed in bilateral external iliac arteries.It was reported that the vessel diameter of the right external iliac artery is 6.5mm ¿ 7.4mm, and that of the left external iliac artery is 6.3mm ¿ 7.7mm.Bare-metal stents were implanted to repair the dissection, and the patient tolerated the procedure.

• Brand Name: GORE® DRYSEAL SHEATH
• 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; flagstaff, AZ ; 9285263030
• MDR Report Key: 6610169
• MDR Text Key: 76590519
• Report Number: 3007284313-2017-00140
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093791
• 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: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2019
• Device Catalogue Number: DSL2428J
• Device Lot Number: 15314532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• 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: 81 YR