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

Model Number	DSF1433
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was discarded at the facility and, therefore, was not available to gore for direct analysis.It should be noted the gore® dryseal flex introducer sheath instructions for use (ifu) state ¿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 or Problem Description
On (b)(6) 2022, a patient underwent endovascular treatment of a left common iliac artery aneurysm using gore® excluder® aaa endoprostheses and a gore® dryseal flex introducer sheath (dsf).During the procedure, an attempt was made to embolize the left internal iliac artery from left-sided access.However, cannulation into the left internal iliac artery was reportedly unsuccessful.The patient¿s right side was accessed, and the left internal iliac artery was successfully embolized.A 14 fr dsf was then inserted from the left side.According to the report, the patient¿s vasculature was extremely tortuous.While advancing the dsf through left external iliac artery, a marked decrease in blood pressure was noted, and the dsf was reportedly outside the vessel.The physician advanced and inflated a molding and occlusion balloon (mob) from the left side to block blood flow at the common iliac artery.Another mob was advanced from the right side and inflated to block blood flow at the distal aorta.The first mob was then deflated, and three stent grafts were implanted as treatment from the left external iliac artery to the middle of the left common iliac artery aneurysm.The procedure went forward to completion, and the patient tolerated the procedure.The physician stated that the left external iliac artery was highly tortuous, and strong resistance was felt when advancing a hard wire.He indicated the access vessel may have been damaged by the wire, and the sheath may have been advanced though a damaged section of the vessel.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Common Device Name: 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: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15266345
• Report Number: 3007284313-2022-02083
• Device Sequence Number: 15097475
• Product Code: DYB
• UDI-Device Identifier: 00733132630004
• UDI-Public: 00733132630004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2024
• Device Model Number: DSF1433
• Device Catalogue Number: DSF1433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/22/2022
• Date Device Manufactured: 05/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male