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

Model Number DSF2033

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682)

Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 11/05/2022

Event Type  Injury  

Manufacturer Narrative

Code "other" was selected as the medical device was discarded at facility.Return not possible.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.

Event Description

On (b)(6) 2017, this patient underwent an endovascular treatment for a thoracic descending aortic aneurysm using conformable gore® tag® thoracic endoprostheses (ctags).Two ctags were implanted (distal tgu313120j, proximal tgu343415j).The patient tolerated the procedure.On (b)(6) 2022 , the patient visited the hospital complaining of chest discomfort.A ct scan images suggested a tear in the graft material of the distal ctag.On the same day, an emergency reintervention was performed.The tear in the graft could not be confirmed by an angiography during the procedure.Also, no endoleak was found either.In this procedure, two gore® tag® conformable thoracic stent graft with active control system (ctag acs) were additionally implanted using a gore® dryseal flex introducer sheath.The previous ctags were successfully relined.However, the right external iliac artery was injured by the sheath.Therefore, a contralateral leg component of gore® excluder® aaa endoprosthesis and a bare-metal stent (luminexx) were additionally placed in the injured site for treatment.Then, the right internal iliac artery was unintentionally half-covered when the contralateral leg component and a bare-metal stent were placed to treat the vessel injury.The patient tolerated the reintervention.

• 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: 15876029
• MDR Text Key: 304429969
• Report Number: 3007284313-2022-02239
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630066
• UDI-Public: 00733132630066
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSF2033
• Device Catalogue Number: DSF2033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2021
• 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: 88 YR
• Patient Sex: Female