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

Catalog Number	DSF1245
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This patient had previously been implanted with endurant¿ devices for abdominal aortic aneurysm.Thereafter, the left common iliac artery (cia) was enlarged and the left internal iliac artery aneurysm (iiaa) was enlarged.On (b)(6) 2024, the patient underwent an endovascular treatment for the left cia enlargement and the left iiaa using gore® excluder® iliac branch endoprosthesis and gore® dryseal flex introducer sheath.The "up & over" technique was used; a dsf1245 was inserted from the right side and advanced over the flow divider of the previously implanted endurant¿ to the left side treatment site.The stent grafts were implanted, and after haemostasis with the preclose technique, decreased blood flow in the right lower limb was observed.Ultrasound confirmed a suspected below-knee embolism, so above the knee (lateral to the knee) was cut down and thrombectomy using a fogarty catheter was performed.The procedure was completed after confirming improved blood flow.The physician reportedly stated as follows: the most recent ct before the procedure showed an increase in thrombus inside of the implanted endurant¿.The thrombus dispersal was most likely caused by manipulations such as the dsf1245 insertion.The occurrence of thrombus dispersal had been anticipated preoperatively.
Additional 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.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 embolization (micro or macro) with transient or permanent ischemia.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
• 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: mami nagashima ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19747183
• Report Number: 3007284313-2024-03365
• Device Sequence Number: 6579308
• Product Code: DYB
• UDI-Device Identifier: 00733132628117
• UDI-Public: 00733132628117
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2026
• Device Catalogue Number: DSF1245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male