MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® DRYSEAL SHEATH; INTRODUCER, CATHETER

Catalog Number DSL2428J

Device Problems Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem Vascular Dissection (3160)

Event Date 05/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017, the patient underwent an endovascular reintervention procedure to treat enlargement of a thoracic aortic aneurysm.The physician advanced a 24-fr gore® dryseal sheath with hydrophilic coating (dsl2428j / lot number unknown) and deployed a conformable gore® tag® thoracic endoprosthesis.Upon withdrawal of the sheath, a left external iliac artery dissection was identified.According to the report, the patient¿s external iliac artery diameter ranged from 6.0 mm to 8.2 mm in the area where dissection was revealed.The physician also had reportedly felt resistance while advancing the sheath.A bare-metal stent was implanted to repair the dissection.The patient tolerated the procedure.

• Brand Name: GORE® DRYSEAL SHEATH
• 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: damon jackson ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6640336
• MDR Text Key: 77544976
• Report Number: 3007284313-2017-00152
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093791
• 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: 05/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DSL2428J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 68 YR