MAUDE Adverse Event Report: BOLTON MEDICAL, INC. TREO ABDOMINAL STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

Catalog Number 28-B2-28-080S

Device Problems Break (1069); Mechanical Problem (1384); Retraction Problem (1536)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  malfunction  

Event Description

"dr.(b)(6) advanced the delivery system over a stiff guidewire without issues.After height and rotation was determined he started to deploy the stent graft.After 5-6 rotations (fixing the black stationary grip and rotating the grey deployment handle) the outer sheath was coming down slightly and at the 7th rotation he heard a click and the handle started to strum.He could move the handle up and down and the outer sheath was no longer deploying.Since the sheath was only slightly down and no stent had opened yet he decided to remove the delivery system and have a look outside the patient.The handle seemed broken, and he decided not to use this one anymore.He used a competitor stent graft instead.Main device is still inside the delivery system since he was unable to deploy." patient outcome - "patient is doing fine, with a competitor graft.".

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.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.

Manufacturer Narrative

Section h6 medical device problem code has been updated following completion of the investigation.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

"dr.(b)(6) advanced the delivery system over a stiff guidewire without issues.After height and rotation was determined he started to deploy the stent graft.After 5-6 rotations (fixing the black stationary grip and rotating the grey deployment handle) the outer sheath was coming down slightly and at the 7th rotation he heard a click and the handle started to strum.He could move the handle up and down and the outer sheath was no longer deploying.Since the sheath was only slightly down and no stent had opened yet he decided to remove the delivery system and have a look outside the patient.The handle seemed broken, and he decided not to use this one anymore.He used a competitor stent graft instead.Main device is still inside the delivery system since he was unable to deploy." patient outcome - "patient is doing fine, with a competitor graft.".

• Brand Name: TREO ABDOMINAL 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: 18379501
• MDR Text Key: 331365103
• Report Number: 2247858-2023-00328
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P190015
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-B2-28-080S
• Device Lot Number: B220519054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2022
• 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 Age: 99 YR