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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-M338145342490U
Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395)
Patient Problems Calcium Deposits/Calcification (1758); Hemorrhage/Bleeding (1888)
Event Date 06/23/2021
Event Type  Injury  
Event Description
Endoleak (type ia): the relay plus device was implanted from the zone 2 position to treat a patient who had a saccular aneurysm in the aortic arch anterior wall.The device was migrated and placed slightly distal side of the aorta (3mm, about the length of the proximal radio plaque marker) from the origin of the left common carotid artery, where it was originally planned to be placed.After the implantation, angiography was performed and confirmed a type ia endoleak.As a tri-lobe balloon catheter (gore) was used inside the device for touch up, but the endoleak did not disappear, the physician determined to implant an additional relay plus device.Then the second device (28-m338100382490u, j170913170) was unpacked and implanted slightly proximal side of the aorta from the proximal radiopaque marker of the first device which was originally planned position.After the touch up, angiography was performed again, but the type ia endoleak was still observed (much less than the first endoleak).Then the left subclavian artery was embolized and the final angiography was performed, which still showed a slight leak into the aneurysm.After anesthesia awareness, the patient was able to move both arms and legs, and the procedure was completed.The physician commented that there was a possibility that the leak would remain due to a calcification in the central sealing part of the aorta, but the leak may stop in the post-discharge phase as the leak finally became small after the additional treatment.(tc#bm210602082) patient outcome - "no health damage.".
 
Event Description
Endoleak (type ia): the relay plus device was implanted from the zone 2 position to treat a patient who had a saccular aneurysm in the aortic arch anterior wall.The device was migrated and placed slightly distal side of the aorta (3mm, about the length of the proximal radio plaque marker) from the origin of the left common carotid artery, where it was originally planned to be placed.After the implantation, angiography was performed and confirmed a type ia endoleak.As a tri-lobe balloon catheter (gore) was used inside the device for touch up, but the endoleak did not disappear, the physician determined to implant an additional relay plus device.Then the second device (28-m338100382490u, j170913170) was unpacked and implanted slightly proximal side of the aorta from the proximal radiopaque marker of the first device which was originally planned position.After the touch up, angiography was performed again, but the type ia endoleak was still observed (much less than the first endoleak).Then the left subclavian artery was embolized and the final angiography was performed, which still showed a slight leak into the aneurysm.After anesthesia awareness, the patient was able to move both arms and legs, and the procedure was completed.The physician commented that there was a possibility that the leak would remain due to a calcification in the central sealing part of the aorta, but the leak may stop in the post-discharge phase as the leak finally became small after the additional treatment.(tc#(b)(4) patient outcome - "no health damage.".
 
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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
MDR Report Key12193209
MDR Text Key262429337
Report Number2247858-2021-00068
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
PMA/PMN Number
P110038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 09/24/2021
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-M338145342490U
Device Lot Number2010200200
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/23/2021
Initial Date FDA Received07/19/2021
Supplement Dates Manufacturer Received06/23/2021
Supplement Dates FDA Received09/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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