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

Catalog Number	DSF2465
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), the access vessel should be of adequate size and appropriate tortuosity of the insertion of the introducer sheath.If the vessel is too small, major bleeding, vessel rupture/perforation, and serious injury to the patient may result.According to the gore® dryseal 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.).
Event or Problem Description
On (b)(6) 2019, the patient underwent an endovascular repair of a descending aortic aneurysm using conformable gore® tag® thoracic endoprostheses.The devices were implanted successfully at the intended position.An angiography identified an endoleak of unknown type (possibly proximal type i or type ii), pertaining to the (b)(4).The physician elected to monitor the endoleak, and conclude the procedure.After removal of a gore® dryseal flex introducer sheath, the access rupture was identified at the right common iliac arteries.The rupture was repaired by implanting a gore® excluder® aaa endoprosthesis contralateral leg and gore® excluder® iliac branch endoprostheses.It was reported that the access vessel was tortuous, and there was difficulty advancing the dsf2465.No further issues were observed, and the patient tolerated the procedure.

• 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: 8671057
• Report Number: 3007284313-2019-00167
• Device Sequence Number: 2182385
• Product Code: DYB
• UDI-Device Identifier: 00733132628407
• UDI-Public: 00733132628407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 05/09/2019

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: 01/16/2021
• Device Catalogue Number: DSF2465
• Device Lot Number: 17769010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2019
• 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: 81 YR