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

Model Number 28-N4-30-164-30U

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2023

Event Type  malfunction  

Event Description

During endovascular repair of thoracic aorta aneurysm.The stent device was removed from the package and prepared in the usual fashion per vendor instruction.The device was not manipulated prior to introduction to the patient.It was introduced to the patient and the stent was deployed.When the device was being removed the "nose cone" came off of the delivery device.The "nose cone" was retrieved in its entirety.Device was saved and sent to materials.Vendor is requesting to have the device return to them for evaluation.Manufacturer response for stent graft system, (brand not provided) (per site reporter).The manufacturer requested device be returned.

• Brand Name: RELAYPRO THORACIC STENT-GRAFT SYSTEM
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): BOLTON MEDICAL INC.; 799 international pkwy; sunrise FL 33325
• MDR Report Key: 16435152
• MDR Text Key: 310146558
• Report Number: 16435152
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28-N4-30-164-30U
• Device Catalogue Number: 28-N4-30-164-30U
• Device Lot Number: 2107290134
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Sex: Female
• Patient Weight: 67 KG