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

Catalog Number 28-M4-32-250-28U

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problems Ischemia (1942); Thromboembolism (2654); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 02/22/2024

Event Type  Death  

Event Description

"vascular damage/ thromboembolism/ death: on (b)(6) 2024, a stent-grafting was performed to treat a descending thoracic aortic aneurysm.The relaypro was implanted centrally and a ctag (gore) was implanted peripherally.Angiography after implantation showed decreased blood flow from the descending aorta to the periphery.Angiography was then performed from near the peripheral portion of the relaypro implantation site, and the abdominal branches were shown, but the blood flow appeared to be slow.As the descending aorta was very shaggy aorta, fragmentation and migration of thrombus was suspected.No additional treatment was performed on the abdominal branches.After removal of a procedural sheath, ultrasound showed poor blood flow and ischemia in the left lower limb, which was determined to be thromboembolism, and a thrombectomy with a catheter was performed in the left lower extremity.The procedure was completed.However, on (b)(6), the patient died of a postoperative embolism.Physician's comment: the patient had severe shaggy aorta and the case was at high risk for thrombus migration.As the delivery system was pushed and pulled during delivery of the relaypro, this manipulation may have been contributed to thrombus formation and migration.Operation type: tevar.Ancillary device: ctag (gore).No image available.Pre-case plan available (schema attached).No additional information available.(tc#(b)(4))".Patient outcome: "the patient died of a postoperative embolism.".

Manufacturer Narrative

Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

"vascular damage/ thromboembolism/ death: on (b)(6), 2024, a stent-grafting was performed to treat a descending thoracic aortic aneurysm.The relaypro was implanted centrally and a ctag (gore) was implanted peripherally.Angiography after implantation showed decreased blood flow from the descending aorta to the periphery.Angiography was then performed from near the peripheral portion of the relaypro implantation site, and the abdominal branches were shown, but the blood flow appeared to be slow.As the descending aorta was very shaggy aorta, fragmentation and migration of thrombus was suspected.No additional treatment was performed on the abdominal branches.After removal of a procedural sheath, ultrasound showed poor blood flow and ischemia in the left lower limb, which was determined to be thromboembolism, and a thrombectomy with a catheter was performed in the left lower extremity.The procedure was completed.However, on (b)(6), the patient died of a postoperative embolism.Physician's comment: the patient had severe shaggy aorta and the case was at high risk for thrombus migration.As the delivery system was pushed and pulled during delivery of the relaypro, this manipulation may have been contributed to thrombus formation and migration.Operation type: tevar.Ancillary device: ctag (gore).No image available.Pre-case plan available (schema attached).No additional information available.((b)(4))".Patient outcome: "the patient died of a postoperative embolism.".

Manufacturer Narrative

Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: RELAY PRO 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: 18981663
• MDR Text Key: 338633427
• Report Number: 2247858-2024-00076
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P200045
• 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: 05/29/2024

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 Catalogue Number: 28-M4-32-250-28U
• Device Lot Number: 2307130424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2023
• 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
• Patient Sex: Male