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

Catalog Number DSF2433

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 10/07/2019

Event Type  Injury  

Manufacturer Narrative

Patient's weight requested, but not provided.

Event Description

On (b)(6) 2019, the patient underwent an endovascular repair of a pseudoaneurysm at the thoracic aorta using a conformable gore® tag® thoracic endoprosthesis.The device was implanted with no reported issues.After removal of a gore® dryseal flex sheath, an angiography identified a rupture at the left external iliac artery that was being used as an access vessel.The rupture was repaired by implanting a gore® excluder® iliac branch endoprosthesis.A transfusion also had to be performed.No further issues were observed, and the patient tolerated the procedure.It was reported that there was resistance during the insertion of the sheath at the left external iliac artery.The diameter or condition of the access vessel, and the cause of the vessel rupture or the resistance were unknown.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: angela brown ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9263198
• MDR Text Key: 165412588
• Report Number: 3007284313-2019-00330
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630950
• UDI-Public: 00733132630950
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2022
• Device Catalogue Number: DSF2433
• Device Lot Number: 20475022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 86 YR