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

Catalog Number 28-N234209342490S

Device Problems Bent (1059); Difficult To Position (1467)

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

Event Date 11/18/2014

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 the relay thoracic stent graft with plus delivery system (the relay nbs plus system).The relay nbs plus system 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 following description of the event was given by dr.(b)(6) just after the procedure; no clinical specialist was with him.A patient presented with a type b dissection and dr.(b)(6) chose a 34 x 200 mm nbs plus stent graft to be positioned in zone 2.Dr.(b)(6) inserted the delivery system inside the access vessel and, in phase 1, advanced the grey handle stopping 2 or 3 cm away from the black handle.With the projection chosen to identify the proximal neck, dr.(b)(6) couldn't see the distal portion of the stent graft and the distal landing zone.For this reason, he decided to advance the relay stent graft in phase 1 stopping very close to the other handle (he wanted to be sure that the stent graft was completely outside the introducer sheath without checking it and we suggested to every customer to go beyond the black line on the ds).He then deployed the stent graft in position 2: everything seemed ok.At this time, dr.(b)(6) moved the c-arm to check if the distal portion of the stent graft was deployed: the last stent was still half crimped inside the primary sheath.Dr.Ricci decided to open the proximal capture (phase 3) and to try and move the inner catheter and the tip up and down.In this way, the relay last stent finally deployed outside the primary sheath.Luckily, the relay didn't move during this manoeuvre, phase 4 was performed without any problem and the implant was successful.".

• 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: mr. stark ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 7319045
• MDR Text Key: 102100859
• Report Number: 2247858-2018-00032
• 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: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-N234209342490S
• Device Lot Number: B140913021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2015
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2014
• 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