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

Catalog Number	DSF2065
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Investigation findings code c21: conclusions pending results of product history review 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
The following was reported to gore: on (b)(6) 2023, the patient underwent a tevar procedure to treat a ulp and a thrombus in the thoracic arch aorta, which was performed before tavi procedure, using two gore® tag® conformable thoracic stent grafts with active control system.A 20fr gore® dryseal flex introducer sheath was inserted from the right femoral artery.Then, two gore® tag® conformable thoracic stent grafts with active control system were delivered through the 20fr sheath and implanted.After all devices were implanted, an angiography and ivus revealed a dissection at the right external iliac artery.This dissection was considered to occur due to the 20fr sheath.A bare metal stent was implanted in the right external iliac artery to treat the dissection.The patient tolerated the procedure.Reportedly, a diameter of the right external iliac artery around the dissection area was 6.5 ¿ 6.6 mm.
Additional Manufacturer Narrative
H.6.Investigation findings 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.The device was discarded at the treating facility and was therefore not available for analysis.H.6.Investigation conclusions code d1102: according to the gore® dryseal flex introducer sheath instructions for use (ifu), adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy 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.If vessel size is smaller than the nominal body od , major bleeding, vessel damage, or serious injury to the patient, including death, may result.Additionally, the ifu states: adverse events that may occur and / or require intervention include, but are not limited to vascular trauma (i.E., dissection, rupture, perforation, tear, etc.) and bleeding.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.The vessel diameter of the injury site was about 6.5-6.6 mm.Per ifu sizing guide for the dsf2065, the id diameter is 6.7mm and od diameter is 7.5mm.If vessel size is smaller than the nominal body od, major bleeding, vessel damage, or serious injury to the patient, including death, may result.Updated h.6.Investigation findings from c21 to c19.Updated h.6.Investigation conclusions from d16 to d1102.

• 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17691560
• Report Number: 3007284313-2023-02743
• Device Sequence Number: 12270079
• Product Code: DYB
• UDI-Device Identifier: 00733132628360
• UDI-Public: 00733132628360
• 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,Followup
• Report Date (Section B): 09/27/2023

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: 12/27/2025
• Device Catalogue Number: DSF2065
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2023
• 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: Female