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

Catalog Number DSF2233

Device Problems Malposition of Device (2616); Difficult to Advance (2920)

Patient Problems Perforation of Vessels (2135); Obstruction/Occlusion (2422)

Event Date 11/01/2023

Event Type  Injury  

Event Description

The following information was reported to gore: on november 1, 2023, this patient underwent an endovascular treatment for a thoracic aortic aneurysm using gore® dryseal flex introducer sheath as an accessory during the procedure.Reportedly, there was some resistance when inserting 22fr dsf.After the deployment of stent grafts, the access angiography revealed vessel damages below in the bifurcation of the right internal iliac artery and the insertion site of the sheath.As a treatment, two stent grafts were implanted from the right common iliac artery to the external iliac artery, and the right internal iliac artery was covered by the proximal device.No additional treatment for the riia being covered was taken.The patient tolerated the procedure.According to the physician, although the patient¿s blood vessels were narrow, there was not much resistance than expected when the device was inserted.It was reported the vessel damages occurred where the access vessel diameters measured around 7.2 mm and 6.4mm.Per the dryseal flex introducer sheath ifu, the outer diameter of a 22fr dryseal sheath is 8.2mm.

Manufacturer Narrative

It should be noted that, per the gore® dryseal flex introducer sheath instructions for use (ifu), the nominal outer body diameter of a 22fr gore® dryseal flex introducer sheath is 8.2mm.If vessel size is smaller than the nominal body od, major bleeding, vessel damage, or serious injury to the patient, including death, may result.Additionally, the ifu states ¿adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.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.

Manufacturer Narrative

H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.

• 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: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18217114
• MDR Text Key: 329129979
• Report Number: 3007284313-2023-02906
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630073
• UDI-Public: 00733132630073
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2023
• 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: 77 YR
• Patient Sex: Female