MAUDE Adverse Event Report: BOLTON MEDICAL INC. RELAYPRO THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

Catalog Number 28-N4-22-099-22X

Device Problems Obstruction of Flow (2423); Device Stenosis (4066)

Patient Problems Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 03/20/2023

Event Type  Injury  

Event Description

Patient had ct imaging completed where narrowing distal to aortic stent graft was noted.A secondary procedure occurred (treatment date not reported at time of this submission) where an additional stent graft was implanted.Dr (b)(6) states the intramural thrombus is possibly related to the device and definitely related to the procedure that was done 4 years ago.Patient outcome - "none at this time.".

Manufacturer Narrative

This device is part of ide study (b)(6), patient id #: (b)(6).This complaint is being reported as part of a company initiative for reporting complaints and adverse events from ide studies.A capa has been initiated to address the matter of timely reporting of complaints.

Manufacturer Narrative

This device is part of (b)(6) study (b)(6), patient id #(b)(6).This complaint is being reported as part of a company initiative for reporting complaints and adverse events from ide studies.A capa has been initiated to address the matter of timely reporting of complaints.

Event Description

Patient had ct imaging completed where narrowing distal to aortic stent graft was noted.A secondary procedure occurred (treatment date not reported at time of this submission) where an additional stent graft was implanted.Dr (b)(6) states the intramural thrombus is possibly related to the device and definitely related to the procedure that was done 4 years ago.Patient outcome - "none at this time.".

• Brand Name: RELAYPRO THORACIC STENT-GRAFT 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: 17231703
• MDR Text Key: 318178433
• Report Number: 2247858-2023-00164
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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: 11/08/2019
• Device Catalogue Number: 28-N4-22-099-22X
• Device Lot Number: 181109228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 06/20/2023
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male