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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC
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BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC Back to Search Results
Catalog Number 28-DH-44-270-34X
Device Problems Material Separation (1562); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2021
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 thoracic stent graft with plus delivery system approved for sale in the us (p110038).The relay branch related event occurred in the us.
 
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.The pt.Had a previous cook t-branch device with a bifurcated stent-graft extending to the common iliacs bilaterally.Apparently the common iliac was stented with an icast for support during/after that procedure.There was some notable resistance trying to advance the device into and through the previously stented iliac and still some resistance in the stented distal aorta.The tip of the outer sheath was advanced to just above the proximal edge of the t-branch device, and dr.(b)(6) started to advance the inner sheath/main body in the normal fashion.There was some noted resistance in the advancement forces.After the 1st stent exited the outer sheath, it was seen on the fluoro screen that the d.S.Tip kind of jumped forward, but the stent-graft and clasp were not advancing with it as they should.I immediately instructed the surgeon to stop the advancement.I checked and the apex holder knob (step #3) was still locked and in its appropriate position.It was clear the d.S.Tip and clasp had moved significantly apart from each other.It was deemed that we could not proceed with advancement and deployment of this device.The deployment grip was then retracted to bring the ds tip back to the graft/clasp and the device was removed from the patient without difficulty.There was no deployment of the stent-graft.At this point, it was noted on the fluoro screen that there appeared to be some type of metal stent in the proximal descending aorta.In reviewing the current and previous fluoro images (from during advancement), it was assumed that this was the icast stent from the iliac artery that must have dislodged and stuck on the ds tip during the advancement through the iliac.Reviewing fluoro images, it was noted in different positions along the d.S.Tip at different times.It could be possible that the icast stent interacted/interfered with the d.S.Tip and sheath/stent-graft causing the unexpected separation.The incisions were closed, and the operation ended.Follow-up from dr.(b)(6) the next day was that the patient was doing well.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 thoracic stent graft with plus delivery system approved for sale in the us (p110038).The relay branch related event occurred in the us.
 
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.The pt.Had a previous cook t-branch device with a bifurcated stent-graft extending to the common iliacs bilaterally.Apparently the common iliac was stented with an icast for support during/after that procedure.There was some notable resistance trying to advance the device into and through the previously stented iliac and still some resistance in the stented distal aorta.The tip of the outer sheath was advanced to just above the proximal edge of the t-branch device, and dr.Lee started to advance the inner sheath/main body in the normal fashion.There was some noted resistance in the advancement forces.After the 1st stent exited the outer sheath, it was seen on the fluoro screen that the d.S.Tip kind of jumped forward, but the stent-graft and clasp were not advancing with it as they should.I immediately instructed the surgeon to stop the advancement.I checked and the apex holder knob (step #3) was still locked and in its appropriate position.It was clear the d.S.Tip and clasp had moved significantly apart from each other.It was deemed that we could not proceed with advancement and deployment of this device.The deployment grip was then retracted to bring the ds tip back to the graft/clasp and the device was removed from the patient without difficulty.There was no deployment of the stent-graft.At this point, it was noted on the fluoro screen that there appeared to be some type of metal stent in the proximal descending aorta.In reviewing the current and previous fluoro images (from during advancement), it was assumed that this was the icast stent from the iliac artery that must have dislodged and stuck on the ds tip during the advancement through the iliac.Reviewing fluoro images, it was noted in different positions along the d.S.Tip at different times.It could be possible that the icast stent interacted/interfered with the d.S.Tip and sheath/stent-graft causing the unexpected separation.The incisions were closed, and the operation ended.Follow-up from dr.Lee the next day was that the patient was doing well.Patient outcome - "there was no negative outcome/patient injury due to this event.".
 
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Brand Name
RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY 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 Key13010268
MDR Text Key287578430
Report Number2247858-2021-00119
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110038
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 03/31/2022
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 Date10/17/2022
Device Catalogue Number28-DH-44-270-34X
Device Lot Number2110010300
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/16/2021
Initial Date FDA Received12/15/2021
Supplement Dates Manufacturer Received11/16/2021
Supplement Dates FDA Received03/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2021
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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