MAUDE Adverse Event Report: GORE GORE-TEX; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problems Backflow (1064); Partial Blockage (1065); Gradient Increase (1270)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Event Description

Medtronic received information that a gore, gore-tex conduit device required intervention (valve-in-valve procedure) due to stenosis and regurgitation.There were no complications at the time of intervention.After implantation the patient started to do sports and experienced dyspnea at physical performance.The patient consulted with the physician and the patient's echo, showed a gradient over 60mmhg at stress, whereas no gradient was evident at rest.A dilatation of the goretex-conduit was performed up to 24mm.After re-dilatation of the conduit, up to 22mm, the gradient was nearly gone.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: GORE-TEX
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): GORE
• MDR Report Key: 17534466
• MDR Text Key: 321159394
• Report Number: MW5141367
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1