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 THORACIC STENT-GRAFT WITH PLUS DELIVERY 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 THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC Back to Search Results
Catalog Number 28-M142195382585S
Device Problems Bent (1059); Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2018
Event Type  malfunction  
Manufacturer Narrative
Bolton medical is voluntarily reporting a device malfunction related to a relay transport device.The relay transport device is not marketed in the us, however it is similar to the relay thoracic stent graft with plus delivery system approved for sale in the us in 2012 ((b)(4)).
 
Event Description
The patient has a thoracic aortic dissection and taking a fenestration operation.The patient had bad iliac access, and tortuous descending aorta.With comparatively big size of sheath, the sheath was bended during advance, so the fenestration point couldn't aline with left subclavian artery and left common carotid artery.Another relay38 stent graft was used to finish the operation.Patient outcome: "use a new taa to finish the operation and the patient recover well.".
 
Event Description
"the patient has a thoracic aortic dissection and taking a fenestration operation.The patient had bad iliac access, and tortuous descending aorta.With comparatively big size of sheath, the sheath was bended during advance, so the fenestration point couldn't aline with left subclavian artery and left common carotid artery.Another relay38 stent graft was used to finish the operation".Patient outcome: "use a new taa to finish the operation and the patient recover well.".
 
Manufacturer Narrative
Bolton medical is voluntarily reporting a device malfunction related to a relay transport device.The relay transport device is not marketed in the us, however it is similar to the relay thoracic stent graft with plus delivery system approved for sale in the us in 2012 (p110038).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7647743
MDR Text Key112894067
Report Number2247858-2018-00139
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 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/25/2020
Device Catalogue Number28-M142195382585S
Device Lot NumberB171020162
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
-
-