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

Model Number	DSF1433
Medical Device Problem Codes	Difficult to Advance (2920); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	12/12/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
B2: exact date of patient death is/remains unknown.H3: code "other" was selected as the medical device was not returned to gore for evaluation.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 endovascular reintervention for a distal type i endoleak occurring after a placement of non gore stentgraft (afx endovascular aaa system).Four gore® excluder® aaa endoprostheses were implanted below the renal arteries, to the right and left common iliac arteries.The procedure was completed without any issues.Immediately after the procedure, the patient was unable to move both legs.Paraplegia was observed and spinal drainage was performed.The patient is being monitored.Reportedly the patient had shaggy thoracic aorta.The physician reported that thrombus might had shifted to the intercostal artery or common carotid artery due to guidewire manipulation.On january 27, 2023 additional information received from gore fsa.During reintervention on (b)(6) when the gore® dryseal flex introducer sheath (dsf1433/(b)(4)) was inserted to the patient, it caught on inner skeleton (stent skeleton placed inside of graft) of an implanted non gore stentgraft (afx), causing migration of the non gore stentgraft to the proximal side.It resulted in a type ib endoleak with aneurysm rupture, and blood loss during reintervention.The procedure was completed without any leak remained, however, postoperative complications may have led to multiorgan failure.The patient expired a few days after the reintervention.Date of the patient death and the cause of death are unknown.No autopsy information obtained.The causal relationship between excluder and the patient death was reportedly unknown.The physician commented that there were possibility of malperfusion and multiorgan failure after reintervention.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16722176
• Report Number: 3007284313-2023-02430
• Device Sequence Number: 7226216
• Product Code: DYB
• UDI-Device Identifier: 00733132630004
• UDI-Public: 00733132630004
• 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
• Report Date (Section B): 04/12/2023

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: 06/28/2024
• Device Model Number: DSF1433
• 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: 02/08/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2022
• 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: Death
• Patient Age: 79 YR
• Patient Sex: Male