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	Perforation of Vessels (2135)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
The following information was reported to gore: on (b)(6) 2019, a patient was treated with gore investigational devices from the arise tbe 14-02 clinical trial, in emergent compassionate use.As part of the procedure, right femoral access was obtained using a 26fr gore® dryseal flex sheath.When the procedure was completed, the sheath was removed.A large segment of vessel endothelium and plaque was disrupted.This was treated by means of endarterectomy and complex primary repair and reconstruction of the femoral artery.The patient tolerated the procedure and was discharged on post-operative day 5.
Event or Problem Description
The following information was reported to gore: on (b)(6), 2019, a patient was treated with gore investigational devices from the arise tbe 14-02 clinical trial, in emergent compassionate use.As part of the procedure, right femoral access was obtained using a 26fr gore® dryseal flex sheath.The sheath was prepped per ifu.The access vessel diameter was 9mm.When the procedure was completed, the sheath was removed.A large segment of vessel endothelium and plaque was disrupted, despite the sheath was periodically rotated during the procedure.This was treated by means of endarterectomy and complex primary repair and reconstruction of the femoral artery.The patient tolerated the procedure.No transfusion was required.The patient was discharged on post-operative day 5.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.H.6.Conclusion code 1: 22: "according to the gore® dryseal flex sheath instruction 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.) additionally it states the dsf2633 sheath is intended to be used in vessels with an internal diameter of at least 9.8mm.

• 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: 9060603
• Report Number: 3007284313-2019-00278
• Device Sequence Number: 11199717
• Product Code: DYB
• UDI-Device Identifier: 00733132630103
• UDI-Public: 00733132630103
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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: 11/13/2021
• Device Catalogue Number: DSF2633
• Device Lot Number: 19999986
• 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
• Initial Report FDA Received Date: 09/15/2019
• Supplement Report FDA Received Date: 10/14/2019
• 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: 85 YR
• Patient Weight: 77