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

Catalog Number	DSF1433
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	11/14/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 information was reported: on (b)(6) 2024, the patient was being treated for a large symptomatic left common iliac artery aneurysm.It was reported that during access the physician was having issues with the wire becoming coiled.During this time the certified registered nurse anesthetist (crna) had noted that the patients blood pressure was low.Reportedly the blood pressure was low during access.The physician obtained bilateral (left and right) common femoral artery (cfa) access and placed a medtronic mvp 9q into the left internal iliac artery via the right cfa access.Next, he placed an amplatz wire into the aorta via the left cfa access with a 5fr 65cm glidecath.This wire and catheter became coiled in the 4.6cm common iliac artery.It had been determined that the left common iliac aneurysm had ruptured.The physician inserted an occlusion balloon in the distal aorta through the right cfa access.The patient did not stabilize, and blood was ordered.A gore® dryseal sheath was advanced and a gore® excluder® aaa endoprosthesis contralateral leg device was implanted but was not long enough to cover the ruptured left common iliac artery.Wire access was lost and the physician chose to perform a cut down repair and ligate the iliac artery.A fem-fem bypass was performed.Ten units of blood was given and the patient coded once the occlusion balloon was removed and had a massive myocardial infarction.The patient expired in the operating room.Patient had very tortuous anatomy, and a history of cardiac disease.It is unknown if the aneurysm ruptured before or after the insertion of the dryseal sheath.
Additional Manufacturer Narrative
The gore® dryseal sheath instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to: vascular trauma (rupture) and death.
Additional Manufacturer Narrative
Update section b, additional information.
Event or Problem Description
After placement of the sheath the crna noted low blood pressure.

• 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: 20860196
• Report Number: 3007284313-2024-03639
• Device Sequence Number: 4032263
• Product Code: DYB
• UDI-Device Identifier: 00733132630004
• UDI-Public: 00733132630004
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2025

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: 09/14/2025
• Device Catalogue Number: DSF1433
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/15/2025; 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2023
• 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: Death; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 74 KG