Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY PLUS THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOLTON MEDICAL, INC. RELAY PLUS THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC Back to Search Results
Catalog Number 28-M330200302390S
Device Problem Failure to Seal (4070)
Event Date 09/28/2020
Event Type  Injury  
Event Description
"aneurysm growth - endo leak type iiia started on (b)(6) 2020 reported as related to the device (branch stent), undetermined whether related to the procedure.The stent was relined on renal right with intervention on (b)(6) 2021." patient outcome: "event is on going.".
 
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.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.Additional information provided on may 21, 2024: "the reported type iiia endoleak was for a second procedure performed using a fevar prothesis (jotec, not tas).The endoleak was for the branch stent and not related to the tevar procedure performed using the relay plus.There was no endoleak reported due to the relay plus device prior to the procedure to implant the fevar graft.Based on this additional information the complaint will be cancelled.".
 
Event Description
"aneurysm growth - endo leak type iiia started on (b)(6) 2020 reported as related to the device (branch stent), undetermined whether related to the procedure.The stent was relined on renal right with intervention on (b)(6) 2021." patient outcome: "event is on going.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RELAY 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 Key19209951
MDR Text Key341361371
Report Number2247858-2024-00102
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 04/29/2024
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 Expiration Date04/06/2020
Device Catalogue Number28-M330200302390S
Device Lot NumberB170901259
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/04/2024
Initial Date FDA Received04/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/06/2016
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 Age64 YR
Patient SexMale
-
-