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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY BRANCH THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

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BOLTON MEDICAL, INC. RELAY BRANCH THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC Back to Search Results
Catalog Number 28-DH-44-270-34X
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2022
Event Type  malfunction  
Manufacturer Narrative
Bolton medical is voluntarily reporting a device malfunction related to the relay branch thoracic stent-graft system.The relay branch device is not marketed in the us; however it is similar to the relay pro thoracic stent graft system approved for sale in the us (p200045).The relay branch related event occurred in the us.This relay branch device was used in compassionate use case (b)(4).
 
Event Description
The device was flushed on the back table and all components including the apex holder knob were in the appropriate positions.The device was brought to the surgical table and inserted into the patient's access vessel via a right common iliac artery conduit.When the device was being advanced in the descending aorta it was noted under fluoroscopy that the tip started to separate from the sheath.The case was paused to analyze if the proximal clasp had separated from the distal clasp.After it was confirmed to still be in place and it was decided to proceed slowly to the deployment site.The graft was deployed successfully and in the intended landing zone with no damage to the patient.This is the second attempt for this compassionate use case, the first one being in november of 2021.A similar failure occurred during this case where the proximal clasp did separate from the distal clasp and the case was aborted.At the time the failure was attributed to the icast device that was caught on the relaybranch delivery system causing a potential wedge between the tip and the outer sheath.The patient had severe scoliosis, small iliacs/access, and previously implanted endovascular devices that could have potentially affected the mechanics of the deployment.Patient outcome - "there was no negative outcome/patient injury due to this event.".
 
Event Description
The device was flushed on the back table and all components including the apex holder knob were in the appropriate positions.The device was brought to the surgical table and inserted into the patient's access vessel via a right common iliac artery conduit.When the device was being advanced in the descending aorta it was noted under fluoroscopy that the tip started to separate from the sheath.The case was paused to analyze if the proximal clasp had separated from the distal clasp.After it was confirmed to still be in place and it was decided to proceed slowly to the deployment site.The graft was deployed successfully and in the intended landing zone with no damage to the patient.This is the second attempt for this compassionate use case, the first one being in (b)(6) 2021.A similar failure occurred during this case where the proximal clasp did separate from the distal clasp and the case was aborted.At the time the failure was attributed to the icast device that was caught on the relaybranch delivery system causing a potential wedge between the tip and the outer sheath.The patient had severe scoliosis, small iliacs/access, and previously implanted endovascular devices that could have potentially affected the mechanics of the deployment.Patient outcome - "there was no negative outcome/patient injury due to this event.".
 
Manufacturer Narrative
Bolton medical is voluntarily reporting a device malfunction related to the relay branch thoracic stent-graft system.The relay branch device is not marketed in the us; however it is similar to the relay pro thoracic stent graft system approved for sale in the us ((b)(6)).The relay branch related event occurred in the us.This relay branch device was used in compassionate use case (b)(4).
 
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Brand Name
RELAY BRANCH THORACIC 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 Key13534082
MDR Text Key288360361
Report Number2247858-2022-00030
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P200045
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 07/07/2022
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 Expiration Date01/23/2023
Device Catalogue Number28-DH-44-270-34X
Device Lot Number2201050131
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/09/2022
Initial Date FDA Received02/15/2022
Supplement Dates Manufacturer Received02/09/2022
Supplement Dates FDA Received07/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2022
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 Age73 YR
Patient SexFemale
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