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

Catalog Number 28-N240204362590S

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2017

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 relay nbs plus device.The relay nbs plus 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

"dr.(b)(6) used a nbs 40-204-36 from his consignment stock and made an in-situ fenestration.When he was about to put it back into the constraining sleeve, the seam of the constraining sleeve burst.He first tried to repair it by sewing it, but did not manage.So, because of the acute condition of the patient, he decided to open another relay nbs from his consignment stock that also had a 25 f delivery system, deployed the graft in vitro and put the home-made fenestrated graft inside this new and unbroken delivery system.He thus successfully managed to implant the by him customized relay inside the patient.The catalog number and lot number of the second relay nbs device used is 28-n238199382590s, lot b150519097.".

• 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: 7325869
• MDR Text Key: 102316471
• Report Number: 2247858-2018-00081
• 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: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-N240204362590S
• Device Lot Number: B150821226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2017
• 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: 58 YR