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

Model Number DSF2233

Device Problem Use of Device Problem (1670)

Patient Problem Vascular Dissection (3160)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing record for the device verified the lot met all pre-release specifications.Also was used dsf1633/21391578 udi# (b)(4).The sheaths were discarded at the facility and not available for analysis.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 22fr sheath minimum id is 7.3mm-8.2mm.According to the ifu size guide, a 16fr sheath minimum id is 5.3mm-6.1mm.It was reported that the diameter of the left external iliac artery was 7mm-7.5mm.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 and gore® dryseal flex introducer sheaths.When a 22 fr sheath was inserted from the left femoral artery, there was resistance and the sheath was not able to be advanced.The 22fr sheath was removed and a 16fr sheath was inserted from the left femoral artery.Then, the 22fr sheath was inserted from the right femoral artery.Reportedly, after all stent grafts were implanted, the angiography imaging identified the left external iliac artery dissection.A bare metal stent was implanted in the dissection site.The patient tolerated the procedure.It was reported that the diameter of the left external iliac artery was 7mm-7.5mm.Additionally, the left common iliac artery and the left external iliac artery were tortuous.It was unknown whether the 22fr or 16fr caused dissection because the angiography was not taken before the 16fr sheath insertion.

• 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: 10519043
• MDR Text Key: 206510760
• Report Number: 3007284313-2020-01061
• 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
• Report Date: 09/10/2020

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: 01/15/2023
• Device Model Number: DSF2233
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/10/2020
• Date Device Manufactured: 01/16/2020
• 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: 78 YR