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

Model Number	DSF1245
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore through the pivotal study for the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device): on (b)(6) 2020, the patient was implanted with a gore® contralateral leg endoprostheses, and a gore® viabahn® vbx balloon expandable endoprostheses with the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device).The patient was being treated for an aortic aneurysm involving the visceral vessel(s).It was reported that on (b)(6) 2020, the patient had an incision infection.Reportedly, the patient came in for an office visit due to left brachial incision redness and tenderness.Incision site was assessed, and wound care performed.Patient prescribed antibiotics and given wound care instructions.The infection was resolved on (b)(6) 2020.
Additional Manufacturer Narrative
Patient medications: heparin, clopidogrel and aspirin.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.
Additional Manufacturer Narrative
H6: added component code of g07001 part/component/sub-assembly term not applicable.H6: code c19 - the device history record was reviewed to ensure that each manufacturing and inspection operation was performed and indicated the product met creganna medical specifications and procedures.A review of the sterilization records indicated the lot met all pre-release specifications.It should be noted the gore® dryseal flex introducer sheath instructions for use (ifu) state adverse events that may occur and/or require intervention include, but are not limited to infection.
Additional Manufacturer Narrative
H6: conclusion code remains unchanged.D1: corrected product code from mih to dyb and common device name from system, endovascular graft, aortic aneurysm treatment to introducer, catheter.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14795369
• Report Number: 3007284313-2022-01985
• Device Sequence Number: 14688150
• Product Code: DYB
• UDI-Device Identifier: 00733132628117
• UDI-Public: 00733132628117
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2023
• 2 Devices were Involved in the Event: 1 2

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: 07/22/2021
• Device Model Number: DSF1245
• Device Catalogue Number: DSF1245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 11/17/2022; 11/17/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 11/29/2022; 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 70 KG