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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC
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BOLTON MEDICAL, INC. RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC Back to Search Results
Catalog Number 28-N4-32-164-32U
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/24/2023
Event Type  Injury  
Event Description
"during procedure graft was deployed and as the main stent graft system came out from the right femoral artery the nose comb was separated from the device and it was left in external iliac artery.Additional information provided on 11/29/2023: this was a very complex procedure with a zone 0 deployment.Once the relay was deployed, all attention went to focusing on re-perfusing the head vessels as the relay covered them per the plan.Once head vessels were patent, dr (b)(6) began to remove the relay pro delivery system.Since the delivery catheter stay in the body while re-perfusing the head vessels, there was an oversight on the stage of deployment sequence on the relay pro.Dr (b)(6) thought he had re-mated the delivery system in step 4 but he did not.As he attempted to remove the delivery system, the nose cone got stuck in the artery and ultimately detached from the delivery system but remained on the wire.They ultimately snared the nose cone and pulled it into a 24 fr gore dryseal sheath and explanted from the body with no clinical consequence observed." patient outcome: "no injury to patient.".
 
Manufacturer Narrative
Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Manufacturer Narrative
Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Event Description
"during procedure graft was deployed and as the main stent graft system came out from the right femoral artery the nose comb was separated from the device and it was left in external iliac artery.Additional information provided on 11/29/2023: this was a very complex procedure with a zone 0 deployment.Once the relay was deployed, all attention went to focusing on re-perfusing the head vessels as the relay covered them per the plan.Once head vessels were patent, dr (b)(6) began to remove the relay pro delivery system.Since the delivery catheter stay in the body while re-perfusing the head vessels, there was an oversight on the stage of deployment sequence on the relay pro.Dr (b)(6) thought he had re-mated the delivery system in step 4 but he did not.As he attempted to remove the delivery system, the nose cone got stuck in the artery and ultimately detached from the delivery system but remained on the wire.They ultimately snared the nose cone and pulled it into a 24 fr gore dryseal sheath and explanted from the body with no clinical consequence observed." patient outcome: "no injury to patient.".
 
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Brand Name
RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM
Type of Device
STENT, ENDOVASCULAR GRAFT, AORTIC
Manufacturer (Section D)
BOLTON MEDICAL, INC.
799 international parkway
sunrise
Manufacturer Contact
megan indeglia
799 international parkway
sunrise, FL 33325
9548389699
MDR Report Key18322953
MDR Text Key330428532
Report Number2247858-2023-00307
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 Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/19/2024
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-N4-32-164-32U
Device Lot Number2303300053
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/13/2023
Supplement Dates Manufacturer Received11/14/2023
Supplement Dates FDA Received01/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2023
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;
Patient Age51 YR
Patient SexFemale
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