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 Problem Obstruction/Occlusion (2422)

Event Date 12/17/2023

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2023, this patient underwent an endovascular treatment for a dissected thoracic aortic aneurysm using gore® tag® conformable thoracic stent grafts with active control system, and gore® dryseal flex introducer sheath as an accessory.The 22fr sheath was inserted from the left side of the patient.On (b)(6) 2023, an occlusion of the left external iliac artery was observed via ct imaging.On (b)(6) 2023, thrombectomy was performed as a treatment.Two stent grafts were implanted in the left external iliac artery, and an additional bare stent in the left common iliac artery.Reportedly that the access vessel occlusion was possibly caused by damaging the intima during the sheath insertion.The physician reportedly mentioned that there were no significant symptoms of the patient as the collateral vessels were developed.The access vessel diameter was narrow just under 7mm, and there was a resistance to advance the 22fr sheath.However, no major issues were observed during intraoperative angiography.

Manufacturer Narrative

H.6: code c19: as reported by creganna the lot met all pre-release specifications.H.6.Code b18: device was discarded at the treating facility and was therefore not available for analysis.H.6.: code e2328: used to capture occlusion of the left external iliac artery 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 (i.E., dissection, rupture, perforation, tear, etc.) h.6.: code d1102: according to the gore® dryseal flex introducer sheath instructions for use, the ifu caution: do not continue advancement or retraction of the catheter or other device into or out of the sheath if there is resistance.Determine the cause of resistance before proceeding.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.

• 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, AZ 86004 ; 9285263030
• MDR Report Key: 18508017
• MDR Text Key: 332898122
• Report Number: 3007284313-2024-02998
• 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: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 12/18/2023
• Date Device Manufactured: 06/28/2023
• 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): Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Female