MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

Catalog Number 28-L2-20-100X

Device Problem Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2014

Event Type  malfunction  

Manufacturer Narrative

During an internal audit, it was determined that complaints for similar devices, and device malfunctions that have the potential to harm the patient if they were to recur, were not reported as per fda guidance.After retrospective review, this event is determined to be mdr reportable.Bolton medical is voluntarily reporting a device malfunction related to a treo device.The treo device is not marketed in the us, however it is similar to the relay thoracic stent graft with plus delivery system approved for sale in the us in 2012 (p110038).

Event Description

"the distal edge of the delivery system of this unit, in the transition between the tip of the device and the edge of the primary sheath was damaged (folded back) during the introduction of the device through the groin in a percutaneous access.The patient was heavily obese and the physician did not pre dilate before attempting the introduction.It was not deemed safe to try and deploy this device.A different device with the same dimensions was deployed without any issues." patient outcome: "the patient was fine and the aaa excluded without endoleak.".

• Brand Name: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
• Type of Device: STENT, ENDOVASCULAR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• Manufacturer Contact: matthew stark ; 799 international parkway; sunrise, FL 33325 ; 8548389699
• MDR Report Key: 7328050
• MDR Text Key: 102232878
• Report Number: 2247858-2018-00089
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-L2-20-100X
• Device Lot Number: 131227002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2014
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2014
• Initial Date FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 63 YR