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

Model Number	28-N4-38-199-34U
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A terumo aortic relay pro 38/34 x 199 mm device was advanced over the lunderquist wire from the left femoral access.There was some difficulty entering the distal aspect of the proximal device with the delivery system but with repositioning of the stiff wire, the device was able to advance without difficulty to the proper level of overlap with the proximal device.The device was then successfully deployed under fluoroscopic guidance with the distal aspect terminating just above the level of the celiac artery.The proximal clasps were released and the nose cone was attempted to bring through the distal device; however, the nose cone inadvertently caught the proximal stent apex of the second device and pulled the proximal portion of the device which was overlapped with the initial device approximately 6-8 cm down, involuting it within the remainder of the device.This was observed under fluoroscopic guidance and removal of the delivery system was aborted.The delivery system was then carefully readvanced which successfully repositioned the proximal portion of the second device much more proximally but not as proximal as needed for acceptable overlap.Additionally, the device appeared somewhat involuted despite readvancement under fluoroscopic guidance.Multiple attempts to remove the delivery system were made and the device could not be detached from the proximal apex of the stent.Following a conversation with the lead engineer from the thoracic endograft company, the metal shaft of the delivery system was rotated multiple times which allowed it to successfully detach from the proximal stent apex of the second endograft.The delivery system was then able to be carefully removed under fluoroscopic guidance in the usual fashion.

• Brand Name: RELAYPRO THORACIC STENT-GRAFT SYSTEM
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): BOLTON MEDICAL INC.; 799 internaltional parkway; sunrise FL 33325
• MDR Report Key: 19220290
• Report Number: 19220290
• Device Sequence Number: 12502847
• Product Code: MIH
• UDI-Device Identifier: 00843576151086
• UDI-Public: (01)00843576151086(11)2023-10-13(17)2025-10-12(10)2310110044
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2024
• Report Date (Section F): 02/06/2024

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: Health Professional
• Device Model Number: 28-N4-38-199-34U
• Device Catalogue Number: 28-N4-38-199-34U
• Device Lot Number: 2310110044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Date Report Sent to FDA: 02/06/2024