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

Catalog Number DSF1633

Device Problem Insufficient Information (3190)

Patient Problem Vascular Dissection (3160)

Event Date 11/13/2023

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2023, this patient underwent endovascular treatment using gore® dryseal flex introducer sheath and gore® excluder® conformable aaa endoprosthesis and gore® excluder® aaa endoprosthesis for abdominal aortic aneurysm.During the procedure, a proximal type i endoleak was noted.The endoleak will be monitored.The was no aneurysm enlargement reported.While the wound was being closed, the pulse was not felt good.Dissection of the left external iliac artery was observed.A metal stent was placed in the dissected lesion.The patient tolerated the procedure.There were no anatomical features reported.The cause of the dissection is unknown, the physician said.

Manufacturer Narrative

H6: code c21 - results pending completion of product history review.According to the gore® dryseal flex introducer sheath instructions for use, adverse events that may occur and / or require intervention include vascular trauma (i.E., dissection, rupture, perforation, tear, etc.).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.

Manufacturer Narrative

H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.Added g3/g4, h1/h2, and h6.

• 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: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18295924
• MDR Text Key: 330113816
• Report Number: 3007284313-2023-02930
• Device Sequence Number: 1
• Product Code: DYB
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DSF1633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Female