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

Catalog Number DSF2433

Device Problems Difficult to Advance (2920); Patient Device Interaction Problem (4001)

Patient Problem Vascular Dissection (3160)

Event Date 02/26/2024

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6)2024, tevar using gore® tag® conformable thoracic stent graft with active control system was planned to treat an arch aortic aneurysm.A 24fr gore® dryseal flex introducer sheath was attempted to insert from the left side, but the sheath was not able to advance because there was a resistance at the left external iliac artery.The dilator only was inserted from the left side and it was able to be advanced.Then, it was tried to advance the sheath from the left side again but it was not success.The approach was changed to the right side and a 24fr gore® dryseal flex introducer sheath was attempted to insert from the right side.However, the sheath was advanced only until the external iliac artery.The dilator only was inserted from the right side but there was a strong resistance.The sheath was tried to insert from the right side again but it was not success.The physician decided to retreat from this procedure without pta or something another try.An angiography for the access site revealed a dissection in the right external iliac artery.The left access had no issue.A bare metal stent was implanted to treat the dissection.The patient tolerated the procedure.Reportedly, two 24fr sheath were used for this procedure but it is unknown which one was inserted from the right side and related to the dissection.It is reported tevar situation is unknown.

Manufacturer Narrative

H3: code "other" was selected as the medical device was discarded at facility.Return not possible.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code d12: according to the gore® dryseal flex introducer sheath instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: vascular trauma (i.E., dissection, rupture, perforation, tear, etc.) as gore was unable to determine which device/device component is involved in this reportable adverse event, the following additional device will be identified in this report: catalog # dsf2433, serial # (b)(6) udi (b)(4).W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: asami aizawa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18910412
• MDR Text Key: 337731691
• Report Number: 3007284313-2024-03107
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630950
• UDI-Public: 00733132630950
• 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: 03/15/2024

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 Catalogue Number: DSF2433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2023
• 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
• Patient Sex: Male