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

Model Number	28-N4-32-164-32U
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Middle-aged female with history of acute type a aortic dissection status post ascending and hemiarch aortic repair along with antegrade thoracic endovascular aortic repair (tevar) and left subclavian stenting, who presented with extremely large aortic arch and descending aortic aneurysm associated with the residual type b aortic dissection, presented for tevar procedure.During the procedure, the graft was deployed and as the main stent graft system came out from the right femoral artery, the nose cone was separated from the device.It was left in the external iliac artery.The right femoral access was upsized to 24 fr and 10 mm snare retrieval was employed.The nose cone was able to be retrieved without major issues.Manufacturer response for thoracic stent system, terumo (per site reporter).They stated an inspection of the thread on the distal indicated found that the epoxy application was in the incorrect location and was not uniformly all the way around.Therefore, the root cause of the reported failure of the tip separating from the delivery system was not procedure compliance.The operators did not comply to the procedure.

• Brand Name: RELAYPRO THORACIC STENT-GRAFT SYSTEM
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): BOLTON MEDICAL INC.; 799 international pkwy; sunrise FL 33325
• MDR Report Key: 19527552
• Report Number: 19527552
• Device Sequence Number: 7574798
• Product Code: MIH
• UDI-Device Identifier: 00843576150591
• UDI-Public: (01)00843576150591(11)230513172505
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2024
• Report Date (Section F): 02/13/2024

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
• Operator of Device: Other
• Device Model Number: 28-N4-32-164-32U
• Device Catalogue Number: 28-N4-32-164-32U
• Device Lot Number: 23033000053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/13/2024