MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0); INTRODUCER, CATHETER

Catalog Number DSF2233

Device Problem Use of Device Problem (1670)

Patient Problem Aortic Dissection (2491)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

According to the instructions for use (ifu) for the gore® dryseal flex introducer sheath; adverse events that may occur include, but are not limited to include: vascular trauma (i.E., dissection, rupture, perforation, tear, etc.).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.If vessel size is smaller than the nominal body od, major bleeding, vessel damage, or serious injury to the patient, including death, may result.Per the instructions for use (ifu), the size gore® dryseal flex introducer sheath associated with this event has a nominal sheath outer diameter of 8.3mm.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

Event Description

On (b)(6) 2019, this patient underwent endovascular treatment for a stanford type b chronic aortic dissection and was implanted with a conformable gore® tag® thoracic endoprosthesis.The device was advanced using a gore® dryseal flex introducer sheath and deployed with no reported issues.Intra-procedure angiography identified a dissection at the origin of the left common and external iliac arteries.A bare metal stent was implanted to treat the dissection.The patient tolerated the procedure with no further issues reported.It was reported that the access vessel at the left side was shaggy, and measured 6.4-7.8mm in diameter.

Manufacturer Narrative

Code 213- a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8687944
• MDR Text Key: 147629064
• Report Number: 3007284313-2019-00172
• 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: 06/21/2019

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: 02/28/2022
• Device Catalogue Number: DSF2233
• Device Lot Number: 20427689
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 75 YR