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

Catalog Number 28-MC38A16038S2590

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

Patient Problems Death (1802); Ischemia (1942); Loss Of Pulse (2562); Multiple Organ Failure (3261); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/07/2020

Event Type  Death  

Event Description

(b)(6) 2020: absence of groin pulsations, laparotomy due to absent celiac artery and sma at completion angiography.(b)(6) 2020: colectomy due to ischemic colon.(b)(6) 2020: multi organ failure.Not determined if the event is device related.Patient outcome - " patient died on (b)(6) 2020.".

Manufacturer Narrative

Bolton medical is voluntarily reporting an event related to a relay plus custom-made device.The relay plus custom-made 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 relay plus custom-made related event occurred in (b)(6).

Event Description

(b)(6) 2020 absence of groin pulsations, laparotomy due to absent celiac artery and sma at completion angiography.(b)(6) 2020 colectomy due to ischemic colon.(b)(6) 2020 multi organ failure.Not determined if the event is device related.Patient outcome - " patient died on (b)(6) 2020.".

• 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: megan indeglia ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 11321142
• MDR Text Key: 231591297
• Report Number: 2247858-2021-00011
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 04/26/2021

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 Expiration Date: 04/02/2021
• Device Catalogue Number: 28-MC38A16038S2590
• Device Lot Number: 2003300229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• 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