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

Model Number	DSF2665
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	09/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #tgmr373720/ serial # (b)(4)/ udi #(b)(4) which is captured in manufacturer report #2017233-2022-03399.Catalog #tgmr313120/ serial # (b)(4)/ udi #(b)(4) which is captured in manufacturer report #2017233-2022-03399.Catalog #tac124020a/ serial # (b)(4)/ udi #(b)(4) which is captured in manufacturer report #2017233-2022-03398.Catalog #tsb121506a/ serial # (b)(4)/ udi #(b)(4) which is captured in manufacturer report #2017233-2022-03398.Catalog #bcl2645/ serial# (b)(4)/ udi #(b)(4) which is captured in manufacturer report #3007284313-2022-02156.A.2.Age at the time of event/date of birth: asked but unavailable a.4.Patient weight: asked but unavailable b.7.Other relevant history, including preexisting medical conditions: asked but unavailable d.10.Concomitant medical products and therapy dates: asked but unavailable 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, the patient underwent emergency treatment of a symptomatic zone 0 dissecting aneurysm using gore® tag® thoracic branch endoprostheses (tbe) and gore® tag® conformable thoracic stent grafts with active control system.A gore® dryseal flex introducer sheath and a gore® tri-lobe balloon catheter were used as accessories in the procedure.The patient's anatomy was reported to be extensively tortuous.On (b)(6) 2022, the gore representative was made aware that the patient had spinal cord ischemia which was observed on the evening of the index procedure.It was reported that a non-prophylactic spinal drain was placed post-procedure and a plan was made to discharge the patient to a rehab center.The spinal cord ischemia is ongoing.On (b)(6) 2022, it was reported that the patient's symptoms are improving.
Additional Manufacturer Narrative
H6: d15 and d12 replaced by d14.
Additional Manufacturer Narrative
H.6.Investigation findings: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation conclusions: code d12 added.According to the gore® dryseal flex introducer sheath instructions for use, potential adverse events that may occur and/or require intervention include, but are not limited to, embolization (micro or macro) with transient or permanent ischemia.H.6.Investigation findings: code c21 updated to code c19 h.6.Investigation conclusions: code d16 updated to code d15.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15592804
• Report Number: 3007284313-2022-02157
• Device Sequence Number: 2215340
• Product Code: DYB
• UDI-Device Identifier: 00733132628421
• UDI-Public: 00733132628421
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2022

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: 04/11/2025
• Device Model Number: DSF2665
• Device Catalogue Number: DSF2665
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 12/16/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/11/2022; 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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: Other
• Patient Sex: Male