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

Catalog Number 28-N238199342590S

Device Problem Kinked (1339)

Patient Problems Death (1802); Tissue Damage (2104); Injury (2348)

Event Date 02/12/2018

Event Type  Injury  

Manufacturer Narrative

Bolton medical is voluntarily reporting a device malfunction related to a relay nbs device.The relay nbs 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).The event occurred in (b)(6).

Event Description

"during insert devices into the aorta while doctor.Advance soft sheath out from hard sheath in the middle of stent device and then cannot moved up, the position step is no.1 of insert soft sheath.So, doctor try to move the whole system up but it cannot move.On fluoroscope, we saw the spiral strut was kink.Dr.(b)(6) decided to move the whole system out from patient." patient outcome: "patient got vascular injury from device cannot move inside the body during operation and stent was kinked.A piece of vessel teared and moved out while device moved outside the body.Finally, a patient passed away 1 day after operation.".

Manufacturer Narrative

Bolton medical is voluntarily reporting a device malfunction related to a relay nbs device.The relay nbs 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 (b)(4).The event occurred in thailand.

Event Description

"during insert devices into the aorta while doctor.Advance soft sheath out from hard sheath in the middle of stent device and then cannot moved up, the position step is no.1 of insert soft sheath.So, doctor try to move the whole system up but it cannot move.On fluoroscope, we saw the spiral strut was kink.Dr.(b)(6) decided to move the whole system out from patient." patient outcome: "patient got vascular injury from device cannot move inside the body during operation and stent was kinked.A piece of vessel teared and moved out while device moved outside the body.Finally, a patient passed away 1 day after operation.".

• 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
• MDR Report Key: 7334153
• MDR Text Key: 102249951
• Report Number: 2247858-2018-00060
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P110038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2020
• Device Catalogue Number: 28-N238199342590S
• Device Lot Number: B171213124
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 02/15/2018
• Supplement Dates FDA Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 42 YR