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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-L2-11-160S
Device Problems Unintended Movement (3026); Activation Failure (3270)
Patient Problem Insufficient Information (4580)
Event Date 02/11/2021
Event Type  malfunction  
Event Description
When the doctor rotated the gray turn knob in the direction of the arrow to start the deployment of the contralateral leg extension, the extension did not start the deployment.Proximal markers of contralateral leg extension began to move downward while the doctor rotated the gray turn knob.The device did not move out of position, the tip remained fixed at the same height, but the proximal extension markers moved away from the tip while the doctor rotated the gray turn knob.At no time was the proximal extension markers observed to expand, so the extension never started the deployment.Finally, as the extension had not been deployed, the system was removed from the patient and a new extension was used.But it was necessary to use 2 extensions to cover the entire length that was intended to be covered with the initial extension.Patient outcome - "there is no apparent damage related to the incident.".
 
Event Description
When the doctor rotated the gray turn knob in the direction of the arrow to start the deployment of the contralateral leg extension, the extension did not start the deployment.Proximal markers of contralateral leg extension began to move downward while the doctor rotated the gray turn knob.The device did not move out of position, the tip remained fixed at the same height, but the proximal extension markers moved away from the tip while the doctor rotated the gray turn knob.At no time was the proximal extension markers observed to expand, so the extension never started the deployment.Finally, as the extension had not been deployed, the system was removed from the patient and a new extension was used.But it was necessary to use 2 extensions to cover the entire length that was intended to be covered with the initial extension.Patient outcome - "there is no apparent damage related to the incident.".
 
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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
MDR Report Key11424097
MDR Text Key253735554
Report Number2247858-2021-00024
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
PMA/PMN Number
P190015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/18/2023
Device Catalogue Number28-L2-11-160S
Device Lot NumberB200201050
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age75 YR
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