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

Catalog Number 28-M4-36-250-36U

Device Problems Failure to Advance (2524); Difficult to Advance (2920); Ejection Problem (4009); Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2024

Event Type  malfunction  

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

"unable to advance the inner sheath: two relaypro stent-grafts were planned to be implanted from zone 3.After the outer sheath of the first stent-graft (28-m4-38-250-34u) was delivered to the a valve level, two stents of the first stent-graft were deployed by rotating the grip when the controller was in the "1", and the inner sheath was attempted to be manually advanced.However, it was too stiff to advance the inner sheath.After that, the inner sheath was advanced by rotating the grip.When reverse technique was attempted, it was too stiff to move the inner sheath, but the inner sheath was managed to be forcefully advanced little by little.During deployment in the "2" position, after about three stents were deployed by rotating the grip, manual manipulation was attempted.However, the physician gave up doing so as it was too stiff.The stent-graft was managed to be deployed and implanted.The second stent-graft (28-m4-36-250-36u) could not be manipulated due to its stiffness, either.It was confirmed that the manual button was pressed during the procedure.The second stent-graft was managed to be deployed and implanted by rotating the grip.Subsequently, the procedure was successfully completed.Physician's comment: this may not be unavoidable since the one with a large diameter was fit in the thin sheath.Operation type: stent graft implantation.No blood loss.No image available.No pre-case plan available.No additional information available.(b)(4).Patient outcome: "no health damage to the patient.".

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

"unable to advance the inner sheath: two relaypro stent-grafts were planned to be implanted from zone 3.After the outer sheath of the first stent-graft (28-m4-38-250-34u) was delivered to the a valve level, two stents of the first stent-graft were deployed by rotating the grip when the controller was in the "1", and the inner sheath was attempted to be manually advanced.However, it was too stiff to advance the inner sheath.After that, the inner sheath was advanced by rotating the grip.When reverse technique was attempted, it was too stiff to move the inner sheath, but the inner sheath was managed to be forcefully advanced little by little.During deployment in the "2" position, after about three stents were deployed by rotating the grip, manual manipulation was attempted.However, the physician gave up doing so as it was too stiff.The stent-graft was managed to be deployed and implanted.The second stent-graft (28-m4-36-250-36u) could not be manipulated due to its stiffness, either.It was confirmed that the manual button was pressed during the procedure.The second stent-graft was managed to be deployed and implanted by rotating the grip.Subsequently, the procedure was successfully completed.Physician's comment: this may not be unavoidable since the one with a large diameter was fit in the thin sheath.Operation type: stent graft implantation: no blood loss; no image available; no pre-case plan available; no additional information available.((b)(4))" patient outcome: "no health damage to the patient.".

• 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: 18799698
• MDR Text Key: 336520784
• Report Number: 2247858-2024-00055
• 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: 03/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 28-M4-36-250-36U
• Device Lot Number: 2308300094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2023
• 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): Other
• Patient Age: 88 YR
• Patient Sex: Female