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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY NBS PRO THORACIC STENT-GRAFT; STENT, ENDOVASCULAR GRAFT, AORTIC
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BOLTON MEDICAL, INC. RELAY NBS PRO THORACIC STENT-GRAFT; STENT, ENDOVASCULAR GRAFT, AORTIC Back to Search Results
Catalog Number 28-NC34N19028S2590
Device Problems Positioning Failure (1158); Premature Activation (1484); Difficult to Remove (1528); Retraction Problem (1536); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/21/2022
Event Type  Injury  
Manufacturer Narrative
Bolton medical is voluntarily reporting an event related to a relay nbs pro custom-made device.The custom made relay nbs pro devices are not marketed in the us, however they are similar to the relay nbs pro thoracic stent graft system approved for sale in the us (p200045).The event occurred in canada.
 
Event Description
While advancing the system into the proximal lading zone in "position 1" there were some challenges getting to the proximal landing zone due to what appeared to be a bit of a ledge near the previous aortic repair/anastomosis.The nose cone appeared to make it past this ledge however the union between the nose cone and inner sheath would not advance.We then noticed that the inner sheath had partially dislodged from the nose cone and the sg had started to butterfly.The sg could not be deployed at this point as the physicians felt we were still too distal.The whole system was pulled back however due to the partially deployed sg it would not track back down the aorta.Multiple attempts were made to pull it back into the outer sheath however this was unsuccessful.After retracting the entire delivery system to the aortic bifurcation (inner sheath still outside the outer sheath) it became obvious that the sg could not be removed from the patient without tearing the femoral artery.The decision was made to deploy the sg in the patients right common iliac in order to get the delivery system out intact.The sg was deployed successfully however while in position 4 and pulling the nose cone back into the delivery system the nose cone detached inside the sg in the patients iliac.The rest of the components were removed successfully.The sg and nose cone were left in the patient.An aui device was then placed, and successful fem-fem crossover was completed as the rcia was now occluded.Overall dr.Price, dr klass and dr faulds were really good about the situation and levelheaded.They are interested in a debrief with the ta team including clinicians and engineers early next week.Imaging will be provided at that time.All components (aside from those left in the patient) are available to return to ta.Patient outcome - "an aui device was then placed, and successful fem-fem crossover was completed as the rcia was now occluded.Patient was extubated and doing well.".
 
Manufacturer Narrative
Bolton medical is voluntarily reporting an event related to a relay nbs pro custom-made device.The custom made relay nbs pro devices are not marketed in the us, however they are similar to the relay nbs pro thoracic stent graft system approved for sale in the us ((b)(6)).The event occurred in canada.
 
Event Description
While advancing the system into the proximal lading zone in "position 1" there were some challenges getting to the proximal landing zone due to what appeared to be a bit of a ledge near the previous aortic repair/anastomosis.The nose cone appeared to make it past this ledge however the union between the nose cone and inner sheath would not advance.We then noticed that the inner sheath had partially dislodged from the nose cone and the sg had started to butterfly.The sg could not be deployed at this point as the physicians felt we were still too distal.The whole system was pulled back however due to the partially deployed sg it would not track back down the aorta.Multiple attempts were made to pull it back into the outer sheath however this was unsuccessful.After retracting the entire delivery system to the aortic bifurcation (inner sheath still outside the outer sheath) it became obvious that the sg could not be removed from the patient without tearing the femoral artery.The decision was made to deploy the sg in the patients right common iliac in order to get the delivery system out intact.The sg was deployed successfully however while in position 4 and pulling the nose cone back into the delivery system the nose cone detached inside the sg in the patients iliac.The rest of the components were removed successfully.The sg and nose cone were left in the patient.An aui device was then placed, and successful fem-fem crossover was completed as the rcia was now occluded.Overall dr.(b)(6), dr (b)(6) and dr (b)(6) were really good about the situation and levelheaded.They are interested in a debrief with the ta team including clinicians and engineers early next week.Imaging will be provided at that time.All components (aside from those left in the patient) are available to return to ta.Patient outcome - "an aui device was then placed, and successful fem-fem crossover was completed as the rcia was now occluded.Patient was extubated and doing well.".
 
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Brand Name
RELAY NBS PRO THORACIC STENT-GRAFT
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 Key15607719
MDR Text Key301757209
Report Number2247858-2022-00156
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P200045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/25/2023
Device Catalogue Number28-NC34N19028S2590
Device Lot Number2205180303
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received09/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2022
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 Outcome(s) Required Intervention; Other;
Patient Age82 YR
Patient SexMale
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