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U.S. Department of Health and Human Services

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

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BOLTON MEDICAL, INC. RELAY NBS PLUS THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC Back to Search Results
Catalog Number 28-N234154302390S
Device Problem Failure to Advance (2524)
Patient Problems Failure of Implant (1924); Stenosis (2263)
Event Date 01/24/2024
Event Type  Injury  
Event Description
"patient is planned for tevar thoracic stent graft.Patient femoral access on left side was small, so decided to get the access from right femoral.Devices crossed the external iliac and reached up till common iliac, but device got stuck before aortic bifurcation in common iliac & could not passed.After multiple attempts device was not able to cross beyond common iliac.As patient's general condition worsened, so dr.Decided to abandon the procedure." patient outcome: "the patient is under medical observation.No injury from our device.".
 
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
"patient is planned for tevar thoracic stent graft.Patient femoral access on left side was small, so decided to get the access from right femoral.Devices crossed the external iliac and reached up till common iliac, but device got stuck before aortic bifurcation in common iliac & could not passed.After multiple attempts device was not able to cross beyond common iliac.As patient's general condition worsened, so dr.Decided to abandon the procedure." patient outcome: "the patient is under medical observation.No injury from our device.".
 
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.
 
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Brand Name
RELAY NBS PLUS 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 Key18753748
MDR Text Key335934786
Report Number2247858-2024-00048
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P110038
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 05/07/2024
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-N234154302390S
Device Lot NumberB210623234
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/24/2024
Initial Date FDA Received02/21/2024
Supplement Dates Manufacturer Received01/24/2024
Supplement Dates FDA Received05/07/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/15/2021
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 Outcome(s) Other;
Patient Age58 YR
Patient SexFemale
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