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

Model Number DSF2233

Device Problem Device Handling Problem (3265)

Patient Problem Vascular Dissection (3160)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

According to the gore® dryseal flex introducer sheath sizing guide, the nominal outside diameter for the 22fr sheath is 8.2 mm.As reported, the diameter of the patients right external iliac artery was under 6 mm.The ifu warns that adequate vessel access is required to introduce the sheath into the vasculature.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.

Event Description

On (b)(6) 2021, this patient underwent endovascular treatment of a thoracic aortic aneurysm using gore® tag® conformable thoracic stent graft with active control system and gore® dryseal flex introducer sheath.The patient had undergone a total arch replacement and a frozen elephant trunk procedure before this procedure (actual date is unknown).When the 22fr gore® dryseal flex introducer sheath was inserted from the right common femoral artery, there was slight resistance.After the gore® tag® device was implanted, when the sheath was removed, strong resistance was noted.Angiography performed after the sheath was removed revealed traumatic injury to the right external iliac artery.Two gore® viabahn® endoprosthesis were implanted to cover the rupture site.The patient tolerated the procedure.Reportedly, the diameter of the right external iliac artery was approximately under 6mm and the artery condition was well.

Manufacturer Narrative

H6: investigation findings and conclusion codes.

• 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
• MDR Report Key: 12441086
• MDR Text Key: 270371589
• Report Number: 3007284313-2021-01578
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630073
• UDI-Public: 00733132630073
• Combination Product (y/n): N
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSF2233
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR