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

Catalog Number DSF2033

Device Problems Difficult to Insert (1316); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Stenosis (2263); Vascular Dissection (3160)

Event Date 10/31/2023

Event Type  Injury  

Manufacturer Narrative

H.6.Code c21: 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.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 Description

On (b)(6) 2023, this patient underwent an endovascular treatment for a thoracic aortic lesion using gore® tag® conformable thoracic stent grafts.A gore® dryseal flex introducer sheath (dsf) was used for access.Reportedly, there was a resistance when inserting the 20fr dsf.After the deployment of stent grafts, angiography revealed a localized dissection in the right common iliac artery.The bare metal stent was placed as a treatment and the patient tolerated the procedure.It was reported the localized dissection occurred where the access vessel diameters measured about 7.7-9.4 mm, with stenosis site measured about 6.0 mm.The physician stated that the localized dissection was expected due to the patient conditions.

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.The physician stated that the localized dissection was expected due to the patient conditions.It was reported the localized dissection occurred where the access vessel diameters measured about 7.7-9.4 mm, with stenosis site measured about 6.0 mm.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 (i.E., dissection, rupture, perforation, tear, etc.).According to the gore® dryseal flex introducer sheath instructions for use (ifu), adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy 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.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.The vessel diameter of the injury site was about 6mm.Per ifu sizing guide for the dsf2033, the id diameter is 6.7mm and od diameter is 7.5mm.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: upon removal of the sheath, precautions should be taken to prevent bleeding, vessel damage, or other serious injury.Continued advancement or retraction against resistance may result in major bleeding, and vessel damage.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18150474
• MDR Text Key: 328302263
• Report Number: 3007284313-2023-02890
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630066
• UDI-Public: 00733132630066
• 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: 12/06/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: DSF2033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• 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; Other; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female