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

Catalog Number DSF1833

Device Problem Retraction Problem (1536)

Patient Problem Vascular Dissection (3160)

Event Date 05/10/2019

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2019, the patient underwent endovascular repair of an abdominal aortic aneurysm with gore® excluder® aaa endoprosthesis using a gore® dryseal flex introducer sheath.It was reported there was resistance during the sheath advancement in the left external iliac artery.After the deployment of the endoprosthesis and removal of the sheath, imaging identified a dissection at the left external iliac artery.A bare-metal stent was implanted to repair the dissection.It was reported vessel diameters in the left external iliac artery are 7.1 ¿ 7.4 mm.The patient tolerated the procedure.

Manufacturer Narrative

According to the gore® dryseal flex introducer sheath instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to, vascular trauma such as dissection.Furthermore, the gore® dryseal flex introducer sheath ifu states that careful evaluation of vessel size, tortuosity, and disease state is required to ensure successful sheath introduction and subsequent withdrawal.If the vessel is not adequate for access, vessel damage may result.If vessel size is smaller than the nominal body od, major bleeding, vessel damage, or serious injury to the patient may result.

• 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: 8652721
• MDR Text Key: 146474201
• Report Number: 3007284313-2019-00159
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630042
• UDI-Public: 00733132630042
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2021
• Device Catalogue Number: DSF1833
• Device Lot Number: 20023330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 86 YR