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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOLTON MEDICAL, INC. TREO ABDOMINAL STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC
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BOLTON MEDICAL, INC. TREO ABDOMINAL STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC Back to Search Results
Catalog Number 28-L2-15-120U
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2023
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
"delivery system breakage: the leg extension stent graft (28-l2-15-120u) on the contralateral side (right) was delivered and deployed successfully and the delivery system was removed from the patient.At that time, the delivery system appeared to have been successfully removed and no abnormalities were noticed.Another leg extension stent graft was delivered and deployed on the ipsilateral side.During that procedure, something similar to the tip of the delivery system was noticed to be present in the leg extension stent graft implanted on the contralateral side.Upon inspection of the delivery system, it was discovered that the delivery system tip was missing.Furthermore, a thin metal shaft was discovered to be extending from the right leg extension stent graft along the guidewire to outside the patient's body.When the proximal end of the metal shaft was pulled, the residual tip moved concurrently, and it was confirmed that the tip and the metal shaft were connected.Continuing to carefully retract the metal shaft, the tip was finally able to be retrieved into the dryseal flex introducer sheath 14fr and removed from the patient.As the tip of the delivery system was successfully removed from the patient, the procedure was continued as initially planned.Subsequently, the procedure was completed without any harm to the patient or any kind of endoleak.Physician's comment: it was found that the tip was not present alone in the patient's body, but was connected to a metal shaft due to the structure of the delivery system, which allowed the tip to be safely removed from the patient.However, the tip should not normally be separated from the delivery system.When removing the delivery system from the contralateral side, the physician did not notice any abnormalities such as stiffness during removal or need for forceful pulling.The physician requested for an investigation to determine the cause of the incident.In addition, please provide information on whether there have been similar cases in the past.Operation type: evar.Blood loss: unknown.No pre-case plan available additional information will be obtained upon request (b)(4).Patient outcome - "no harm to the patient.".
 
Event Description
"delivery system breakage: the leg extension stent graft (28-l2-15-120u) on the contralateral side (right) was delivered and deployed successfully and the delivery system was removed from the patient.At that time, the delivery system appeared to have been successfully removed and no abnormalities were noticed.Another leg extension stent graft was delivered and deployed on the ipsilateral side.During that procedure, something similar to the tip of the delivery system was noticed to be present in the leg extension stent graft implanted on the contralateral side.Upon inspection of the delivery system, it was discovered that the delivery system tip was missing.Furthermore, a thin metal shaft was discovered to be extending from the right leg extension stent graft along the guidewire to outside the patient's body.When the proximal end of the metal shaft was pulled, the residual tip moved concurrently, and it was confirmed that the tip and the metal shaft were connected.Continuing to carefully retract the metal shaft, the tip was finally able to be retrieved into the dryseal flex introducer sheath 14fr and removed from the patient.As the tip of the delivery system was successfully removed from the patient, the procedure was continued as initially planned.Subsequently, the procedure was completed without any harm to the patient or any kind of endoleak.Physician's comment: it was found that the tip was not present alone in the patient's body, but was connected to a metal shaft due to the structure of the delivery system, which allowed the tip to be safely removed from the patient.However, the tip should not normally be separated from the delivery system.When removing the delivery system from the contralateral side, the physician did not notice any abnormalities such as stiffness during removal or need for forceful pulling.The physician requested for an investigation to determine the cause of the incident.In addition, please provide information on whether there have been similar cases in the past.Operation type: evar blood loss: unknown.Image available no pre-case plan available additional information will be obtained upon request (tc#(b)(4))".Patient outcome - "no harm 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.
 
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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 Key18416042
MDR Text Key331641641
Report Number2247858-2023-00332
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P190015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial,Followup
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 Number28-L2-15-120U
Device Lot Number2303170180
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/28/2023
Initial Date FDA Received12/28/2023
Supplement Dates Manufacturer Received11/28/2023
Supplement Dates FDA Received03/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age99 YR
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