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

Catalog Number	DSF2633
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records is being requested.According to the gore® dryseal flex sheath instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to: blood loss and vascular trauma.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018, a patient underwent endovascular treatment in the thoracic aorta, zone 0, with gore® tag® thoracic branch endoprostheses and a conformable gore® tag® thoracic endoprosthesis as distal extension to aortic component.According to the report all devices were positioned and implanted without issue.A gore® dryseal flex sheath was used for access.During the procedure an iliac artery rupture occurred.Estimated blood loss was 2500ml.Blood replacement products were given and a right femoral artery repair was performed.The patient tolerated the procedure.Post-operatively the patient had low blood pressure, respiratory insufficiency and atrial fibrillation, which were all medically managed.
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.
Additional Manufacturer Narrative
According to the gore® dryseal flex sheath instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to: blood loss and vascular trauma.Additionally, the sizing for a 26fr sheath requires a minimum access vessel diameter of 8.7mm.This patient's access vessel diameter was 6.8-8.7mm.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8108813
• Report Number: 3007284313-2018-00331
• Device Sequence Number: 2266663
• Product Code: DYB
• UDI-Device Identifier: 00733132630103
• UDI-Public: 00733132630103
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2021
• Device Catalogue Number: DSF2633
• Device Lot Number: 18444109
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 12/19/2018; 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 65