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

Catalog Number DSF2233

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Vascular Dissection (3160); Ruptured Aneurysm (4436)

Event Date 12/23/2023

Event Type  Injury  

Manufacturer Narrative

H.6.: code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6: code b18: the device was discarded at the treating facility and was therefore not available for analysis.H.6.: code d12: according to the gore® dryseal flex sheath instructions for use, adverse events with may occur and/or require intervention including, but not limited to, vascular trauma.H.6.: code d1102: do not attempt to advance or withdraw guidewire, catheter, or other device through the introducer sheath or dilator if resistance is felt.Use fluoroscopy to determine the cause.Continued advancement or retraction against resistance may result in major bleeding, vessel damage, serious injury to the patient, or damage to / breakage of the guidewire, catheter, or other device.H.6.: code d1001: according to the gore® dryseal flex sheath instructions for use, adverse events with may occur and/or require intervention including, but not limited to: vascular trauma (i.E., dissection, rupture, perforation, tear, etc.) adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.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

The following information was reported to gore: on december 23, 2023, this patient underwent endovascular treatment for a thoracic aortic aneurysm suspected of imminent rupture using gore® dryseal flex introducer sheath and gore® tag® conformable thoracic stent graft with active control system.A 22fr sheath was inserted from right side.The patient's access vessel was narrow, and there was resistance when advabcing the sheath.All stent grafts were successfully implanted, and during the removal of the sheath, dissection and rupture in the right external iliac artery were observed.For repair, a bare metal stent was implanted at the dissection site and a stent graft was implanted at the rupture side.Reportedly, the right external iliac artery was 5.3 mm, and the physician understood the risk of vessel injury.

• 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: kathryn irwin ; 1505 n. fourth street; flagstaff ; 9285263030
• MDR Report Key: 18545120
• MDR Text Key: 333268452
• Report Number: 3007284313-2024-03011
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2023
• 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: 94 YR
• Patient Sex: Female