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

Catalog Number 28NC46N27032S2690

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

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 11/26/2016

Event Type  Injury  

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 relay nbs plus custom device.The relay nbs plus custom 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).This complaint was involved with four devices.Device 1 is being reported under mdr 2247858-2018-00115.Device 2 is being reported under mdr 2247858-2018-00116.Device 3 is being reported under mdr 2247858-2018-00117.Device 4 is being reported under mdr 2247858-2018-00118.

Event Description

"patient was proposed for treatment with relaybranch device, because he was deemed unfit for open repair by physician.Implantation of relaybranch device and relay extension went as planned.During the procedure there was constant monitoring of possible emboli in the sat's via trans cranial doppler; no clinical abnormalities were observed during implant." patient outcome: "according to physician, the patient developed neurological symptoms and massive brain damage.Approximately 3 days after the implant patient was abstained.".

• 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: 7331702
• MDR Text Key: 102190344
• Report Number: 2247858-2018-00115
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 28NC46N27032S2690
• Device Lot Number: B161021307
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 03/12/2018
• 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): Death; Required Intervention
• Patient Age: 73 YR