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

Catalog Number 28-L2-24-160S

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

"following percutaneous access a 24mm x 160mm limb was positioned over a lundequist wire within the previous right iliac limb to reline and extend the limb up to the iliac bifurcation.The patient's groin did not feel heavily scarred and there was no significant iliac tortuosity.The limb was flushed/prepared according to ifu and was placed bareback' into the groin with no additional sheath system.Upon deploying the limb the first 2-3 stent struts opened satisfactorily using the mechanical advantage rotation handle.It was noted to be slightly stiff to turn the handle, but not out-with normal limits.Visualization of the deployment was poor due to patient habitus despite maximal fluoroscopy doses and magnificantion and a lack of distal sheath radio-opaque marker.The handle was turned completely until it reached the end of the track at which point it was noted that the rest of the stent graft had failed to deploy/sheath had failed to pull any further back after releasing the initial 2-3 struts.On inspection at the groin it was noted that the outer sheath had been pulled apart/stretched/unwound leaving the inner plastic and metal component visible.Presumbily after deploying 2-3 struts the tip of the outer sheath had become stuck, either externally against the patient or internally against the stent graft (which i believe more likely).As the sheath tip was stuck the deployment handle therefore just stretched/pulled apart the sheath rather than pulling it back.An attempt was made at pinning the stent graft internally with a contralateral balloon but this was unable to generate sufficient counter traction to remove the outer sheath.Ultimately, the groin was cut down onto and the half deployed stent graft was pulled out via an ateteriotomy.The patients external iliac and fermoral arteries were relatively big and so this was able to be performed without significant injury.The remainder of the procedure was completed successfully with new stent grafts without issue and the patient recovered as expected." patient outcome - "patient required femoral cut down and arteriotomy to remove the partly deployed stent graft.Otherwise the procedure was completed without consequence using a new stent graft.The patient's endo leak and rupture were successfully treated and recovering well/as expected.".

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: 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: 18948931
• MDR Text Key: 339218141
• Report Number: 2247858-2024-00068
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/20/2024

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-L2-24-160S
• Device Lot Number: B231004205
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/21/2024
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 99 YR
• Patient Sex: Male