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

Model Number	DSF1433
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Aneurysm (1708); Pseudoaneurysm (2605); Vascular Dissection (3160)
Date of Event	10/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device is going to be conducted.The investigation is in process.Further information will be provided.The sheath was discarded at the facility and is not available for analysis.No treatment was required.The event is ongoing.The physician is monitoring the patient.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) 2018, the patient underwent a treatment of an abdominal aortic aneurysm measuring 51mm with a gore®excluder® conformable aaa endoprosthesis and gore® excluder® aaa endoprostheses.A gore® dryseal flex introducer sheath (dsf1433/ (b)(4) was used for access at the right femoral artery.The patient tolerated the procedure.On (b)(6) 2019, a right femoral artery pseudoaneurysm was determined.No treatment was required.The event was ongoing.The physician was monitoring the patient.Follow up ct scans from (b)(6) 2019 till (b)(6) 2022, showed that the maximum abdominal aortic aneurysm diameter decreased in size from 56mm to 52mm.Follow up on (b)(6) 2020, showed that the maximum abdominal aortic aneurysm diameter was 57mm.On (b)(6) 2019, a right common iliac artery pseudoaneurysm was determined.No treatment was required.The event is ongoing.The physician was monitoring the patient.On (b)(6) , 2022, the additional information was received from the site that the physician believes that a right femoral artery pseudoaneurysm was caused during the vessel being accessed during the implant procedure on (b)(6) 2018.When reviewing the ct scans, the physician did not see a right common iliac artery pseudoaneurysm.Also, the physician does not believe that the endoprosthesis caused the pseudoaneurysm.No plans to repair the pseudoaneurysm.The physician is monitoring the patient.Based on the patient¿s last clinic visit on (b)(6) 2022, the patient was noted to be ¿doing quite well¿ with no complaints or signs of disease progression.
Additional Manufacturer Narrative
H6: code c19: a review of the manufacturing records for the device verified the lot met all pre-release specifications.The sheath was discarded at the facility and is not available for analysis.Code f28 was used to cover the following: no treatment was required.The event is ongoing.The physician is monitoring the patient.The physician believes that a right femoral artery pseudoaneurysm was caused during the vessel being accessed during the implant procedure on (b)(6) 2018.According to the gore® dryseal flex introducer sheath instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to vascular trauma and bleeding.
Additional Manufacturer Narrative
H6: added code d1001 under investigation conclusions.Code d12 remains unchanged from previous 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15785347
• Report Number: 3007284313-2022-02206
• Device Sequence Number: 3113227
• Product Code: DYB
• UDI-Device Identifier: 00733132630004
• UDI-Public: 00733132630004
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2023

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: 07/25/2020
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 11/23/2022; 02/17/2023
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 12/04/2022; 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2018
• 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: Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White