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

Model Number DSF1833

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 02/02/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, the patient underwent endovascular treatment of an infected thoracic aortic aneurysm where gore® dryseal flex introducer sheath was used as an accessory during the procedure.A 18fr sheath was inserted from the right femoral artery into the patient.Reportedly, the sheath insertion was difficult due to narrow access caused by calcification.Percutaneous transluminal angioplasty was performed by 5mm and 7mm pta balloon catheters to dilate the access site.The stent grafts placement was completed without any issues.Because the right common iliac artery could have been injured by the sheath insertion, it was decided to add a stent graft from the right common iliac artery to the right external iliac artery at the time of the sheath removal.The right internal iliac artery was covered by the stent graft.It was observed that the intima of the puncture site was damaged and therefore it was surgically repaired.After the repair, the repaired suture site was narrowed, resulting in poor blood flow, so an additional stent graft was placed at the repaired site.The patient tolerated the procedure.According to the report, the access vessel measured 5-5.7mm in diameter.

Manufacturer Narrative

Code "other" was selected as the medical device was discarded at facility.Return not possible.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.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Type of Device: 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: 16467904
• MDR Text Key: 310515848
• Report Number: 3007284313-2023-02370
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630042
• UDI-Public: 00733132630042
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSF1833
• Device Catalogue Number: DSF1833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female