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

Model Number DSF2433

Device Problem Use of Device Problem (1670)

Patient Problem Vascular Dissection (3160)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing record for the device verified the lot met all pre-release specifications.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, 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.According to the ifu size guide, a 24fr sheath minimum id is 8.0mm-8.8mm.It was reported that the diameter of the left external iliac artery was 7.3mm ¿ 7.6mm.Do not attempt to advance the introducer sheath or dilator if resistance is felt.Continued advancement or retraction against resistance may result in major bleeding, vessel damage, serious injury to the patient, or damage to the other device.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.).

Event Description

On (b)(6) 2020, the patient underwent endovascular treatment of a thoracic aortic aneurysm using a gore® tag® conformable thoracic stent graft with active control system, a gore® tag® conformable thoracic endoprosthesis and a gore® dryseal flex introducer sheath (24fr).After the gore® tag® conformable thoracic stent graft with active control system was implanted, the angiography revealed an endoleak (a proximal type i endoleak or a type ii endoleak originating from the left common carotid artery).No additional treatment for the endoleak was performed.The physician decided to monitor the patient.When the 24fr sheath was removed, the left external iliac artery rupture was observed.An iliac extender endoprosthesis was implanted to arrest bleeding.The procedure was completed successfully.The patient tolerated the procedure.Reportedly the diameter of the left external artery around the rupture site was 7.3 ¿ 7.6 mm.The physician stated that there was resistance during advancing the sheath and the left access vessel was narrow and calcificated.

• 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: 10610435
• MDR Text Key: 209350163
• Report Number: 3007284313-2020-01083
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630950
• UDI-Public: 00733132630950
• 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
• Report Date: 09/30/2020

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 Expiration Date: 04/17/2021
• Device Model Number: DSF2433
• Device Catalogue Number: DSF2433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 09/30/2020
• Date Device Manufactured: 04/18/2018
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 87 YR