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

Catalog Number	DSF2033
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	07/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2024, the patient underwent an endovascular procedure to treat an aneurysm utilizing the gore® tag® thoracic brach endoprostheses (aortic component, aortic extender, and aortic side branch), gore® dryseal flex introducer sheath and gore® molding & occlusion balloon catheter.It was reported that the physician implanted all 3 tbe devices without any issues.An angiogram was taken after the case.The patient tolerated the procedure.After the procedure, the fsa received a call from the physician.The patient was having difficulty moving the left side of their body.The physician performed a cat scan and determined that the patient experienced a stroke.The patient was put on the hospital¿s stroke protocol immediately.The physician does not know what caused the issue.The fsa stated that prior to the procedure, the patient had a spinal drain in place.The fsa stated that prior to device implantation, the physician performed a left subclavian artery to left common carotid extra-anatomic bypass.The bypass was performed because the aneurysm was located in a place that would of have required the physician to extend over the top of the left common carotid so the physician wanted to perfuse it first.Code 1001-e: unknown: to capture stroke incident with unknown cause.
Additional Manufacturer Narrative
H6: code c21 - results pending completion of product history review.H6: code b18 - the device was discarded therefore, was not available for direct analysis by gore.H6: code a26- used to capture insufficient information available to determine if gore device contributed to stroke.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
Added g3/g3, h1/h2, h6.H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.

• 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: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19840608
• Report Number: 3007284313-2024-03392
• Device Sequence Number: 7752382
• Product Code: DYB
• UDI-Device Identifier: 00733132630066
• UDI-Public: 00733132630066
• 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
• Report Date (Section B): 08/19/2024

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
• Device Expiration Date: 08/22/2026
• Device Catalogue Number: DSF2033
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2023
• 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
• Patient Weight: 150 KG