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

Catalog Number 28-NC42N22036N2690 

Device Problems Detachment Of Device Component (1104); Retraction Problem (1536); Failure to Align (2522); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981); Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 07/18/2014

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 the relay thoracic stent graft with plus delivery system (the relay nbs plus custom system).The relay nbs plus custom 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 ((b)(4)).

Event Description

"the delivery system was inserted with the flush port on the grey deployment grip facing a little medial (1 o'clock) in order to accommodate the twisting of the stent graft given by the offset between ascending and descending aorta, and without any problem it was brought to the middle portion of the descending aorta.Once in place, it was advanced in position_1 and again with no problem the inner sheath was positioned onto the designed proximal landing zone (ascending portion of the aorta).At this point the proximal portion of the fenestration seemed to be well oriented, while the distal end was still in need of a little rotation in order to be put on top of lcca (the tube-markers along the fenestration weren't aligned, and the proximal end of the stent-graft looked different from the usual).Since the surgeons started to rotate, the delivery system (both the handles at the same time), the distal portion of the device started to slowly twist, leading the distal portion of the device to curl up, while the proximal portion of the whole graft didn't move whatsoever (the proximal markers of the cm device remained still).After having tried for a good hour to reach the correct positioning of the fenestration, both rotating and moving forward and backward the delivery system without being able to reach an acceptable placement, we were about to abort the procedure and to deploy the stent-graft below lcca when we realized the proximal end of the stent-graft was completely detached from the delivery system (while trying to retract the whole device, the tip of the delivery system moved into the stent-graft).In position 4, holding still the grey handle, the stainless steel rod was slowly pushed forward in order to stretch the stent-graft and to advance the tip to its original position.At this point, holding still the stainless steel rod, the grey grip was pulled backward to deploy the graft.Something was wrong with the delivery system and the constraining sleeve was not retracted.It was now clear that the constraining sleeve was tear from the transparent inner catheter (the one attached to the grey handle).After several other hours of attempts the device had to be explanted since the 16mm constraining sleeve couldn't pass through the abdominal stent-graft already in place.".

• 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: 7318646
• MDR Text Key: 101768513
• Report Number: 2247858-2018-00027
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 28-NC42N22036N2690
• Device Lot Number: B140528085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2014
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR