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

Catalog Number 28-L2-13-140S

Device Problem Mechanical Problem (1384)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

This complaint was involved with two devices.Device 1 is being reported under mdr-2247858-2024-00050 and device 2 is being reported under mdr-2247858-2024-00056.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

"(b)(6) was implanted through a 20 fr.Sheath, all target vessels canulated and stented without issues.Only had to stent the iliacs[?].Due to long segment several legs needed.Advancing 28-l2-15-160s in the left groin without issues.Started to deploy after a few turns we didn't see the outer sheath retract.After a few more turns we heard 2 loud clicks and the physician couldn't deploy any further! since the leg didn't open we removed the ds from the groin and could visualize the outer sheath being torn and broken.Advancing a new 15x160 and deploying without issues, advancing extension 15x100 and deploying without issues.Advancing another extension (sealing in leia) 28-l2-13-140s and the same issue occurred.Turning didn't deploy the leg and after a few turns we heard 1 loud click! physician couldn't deploy and the ds was removed from the groin, outer sheath didn't seem torn or broken this time.We then used a medtronic limb (16-13-156) to finalize the procedure.Also needed another bridge medtronic 16-16-124 to solve a type 3 endoleak.(so 4 legs on the left side!!) but end result was good." patient outcome: "aaa 14cm with type 1a and bilateral type 1b endoleak excluded.Patient is doing fine.".

• 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 33029
• Manufacturer Contact: megan indeglia ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 18676939
• MDR Text Key: 336078779
• Report Number: 2247858-2024-00056
• 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
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-L2-13-140S
• Device Lot Number: B230907054
• Date Manufacturer Received: 01/25/2024
• 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: 78 YR
• Patient Sex: Male