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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-L2-17-120U
Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2024
Event Type  Injury  
Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported under mdr 2247858-2024-00065, device 2 is being reported under mdr 2247858-2024-00066 and device 3 is being reported under mdr 2247858-2024-00067.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
"28x80 bifur device was deployed appropriately & accurately.Due to poor imaging in the room, the ipsi limb was deployed prematurely.This was not realized by anyone in the room at that time.Cannulation of the gate was attempted from the contra side, the wire was easily in the graft.Marker pig was spun freely to verify wire was within the graft.Ivus was used to verify location.17x120 limb was deployed at minimum overlap on the contra side.17x120 limb on ipsi side was deployed between minimum and maximum overlap.Dr.Then repositioned imaging and we then realized the contra gate had no limb in it.We then ivus both sides to confirm that both the contra and ipsi limb were within the ipsi main body limb.Ivus proved the ipsi limb was compromised by pressure from the contra limb.Dr then decided to convert to aui using aortic cuff." patient outcome - "via the contra side, an aortic cuff was advanced and deployed in mid main body of the bifurcated device and the distal part of the cuff was deployed in the proximal contra limb.Aortic balloon was advanced and ballooned where the bifur and the cuff overlap and from the flow divider down to the distal iliac.Post angiogram showed a small type 3 leak through the ipsi limb.We then deployed a 15x100 treo limb & then re-balloned from the flow divider down through the 15x100 limb.Post angiogram showed no endoleak, dr decided to ivus again to verify maximum luminal gain and sufficient flow throughout the graft and limbs.Dr was satisfied with result of ivus and verification of no leaks.Then a fem-fem bypass was performed without incident.Patient was discharged from hospital wednesday am with satisfactory outcome.".
 
Event Description
"28x80 bifur device was deployed appropriately & accurately.Due to poor imaging in the room, the ipsi limb was deployed prematurely.This was not realized by anyone in the room at that time.Cannulation of the gate was attempted from the contra side, the wire was easily in the graft.Marker pig was spun freely to verify wire was within the graft.Ivus was used to verify location.17x120 limb was deployed at minimum overlap on the contra side.17x120 limb on ipsi side was deployed between minimum and maximum overlap.Dr.Then repositioned imaging and we then realized the contra gate had no limb in it.We then ivus both sides to confirm that both the contra and ipsi limb were within the ipsi main body limb.Ivus proved the ipsi limb was compromised by pressure from the contra limb.Doctor then decided to convert to aui using aortic cuff." patient outcome - "via the contra side, an aortic cuff was advanced and deployed in mid main body of the bifurcated device and the distal part of the cuff was deployed in the proximal contra limb.Aortic balloon was advanced and ballooned where the bifur and the cuff overlap and from the flow divider down to the distal iliac.Post angiogram showed a small type 3 leak through the ipsi limb.We then deployed a 15x100 treo limb & then re-balloned from the flow divider down through the 15x100 limb.Post angiogram showed no endoleak, dr decided to ivus again to verify maximum luminal gain and sufficient flow throughout the graft and limbs.Doctor was satisfied with result of ivus and verification of no leaks.Then a fem-fem bypass was performed without incident.Patient was discharged from hospital on wednesday am with satisfactory outcome.".
 
Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported under mdr 2247858-2024-00065, device 2 is being reported under mdr 2247858-2024-00066 and device 3 is being reported under mdr 2247858-2024-00067.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 Key18937820
MDR Text Key338068512
Report Number2247858-2024-00067
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P190015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/03/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number28-L2-17-120U
Device Lot Number2311030259
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/19/2024
Supplement Dates Manufacturer Received02/19/2024
Supplement Dates FDA Received04/03/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/10/2023
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 Outcome(s) Other; Required Intervention;
Patient Age77 YR
Patient SexMale
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