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

Catalog Number	DSF2265
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2023, the patient underwent an endovascular treatment of a thoracic aortic aneurysm using gore® dryseal flex introducer sheath, gore® tag® conformable thoracic stent graft with active control system, and gore® excluder® conformable aaa endoprosthesis.A dsf1833 was inserted through the left femoral artery and passed through the left common iliac artery, although there was some resistance during passage.After implanting a cxa280005, the sheath was replaced with a dsf2265, and the dsf2265 was inserted although there was some resistance.Access angiography after all stent grafts implantation revealed dissection of the left common iliac artery, but no treatment was performed since there was no bleeding.The patient was placed under observation.Reportedly, the diameter of the left common iliac artery in the area where dissection occurred was reported to be about 6.1-7.1 mm.The physician reportedly stated as follows: because the patient's access vessel was originally narrow, dissection was considered unavoidable.
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 6.1 to 7.1 mm.Per ifu sizing guide for the dsf2433, the id diameter is 7.3mm and od diameter is 8.2mm.If vessel size is smaller than the nominal body od, major bleeding, vessel damage, or serious injury to the patient, including death, may result.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: 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 6.1 to 7.1 mm.Per ifu sizing guide for the dsf2265, the id diameter is 7.3mm and od diameter is 8.2mm.If vessel size is smaller than the nominal body od, major bleeding, vessel damage, or serious injury to the patient, including death, may result.In the additional manufacturer narrative, the instructions for use for code d1102 should be deleted, and replaced with the replacement text in the additional manufacturer narrative section of this report.

• 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: 17958605
• Report Number: 3007284313-2023-02835
• Device Sequence Number: 5282776
• Product Code: DYB
• UDI-Device Identifier: 00733132628384
• UDI-Public: 00733132628384
• 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,Followup
• Report Date (Section B): 10/18/2023

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: 02/21/2026
• Device Catalogue Number: DSF2265
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2023
• 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 Age: 73 YR
• Patient Sex: Female