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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
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BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC Back to Search Results
Catalog Number 28-M340195362590U
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/24/2018
Event Type  malfunction  
Event Description
"prior to the case a total arch debranching had been done in an open procedure by dr.(b)(6) and a carotid-subclavian bypass was done in a separate open procedure by dr.(b)(6).The patient had a dissection of the descending thoracic aorta.Percutaneous access was done in both groins.Case went normally until the physician went to take the device out of the patient and the delivery system tip came off inside of the patients femoral artery just proximal of where percutaneous access was gained in the right groin.A clamp was successfully used to retrieve the delivery system tip.A selective angiogram was done to confirm that the artery was not damaged and perclose was used to close the artery." patient outcome: "patient doing well throughout procedure, during event & 24 hours post procedure.".
 
Event Description
"prior to the case a total arch debranching had been done in an open procedure by dr.(b)(6) and a carotid-subclavian bypass was done in a separate open procedure by dr.(b)(6).The patient had a dissection of the descending thoracic aorta.Percutaneous access was done in both groins.Case went normally until the physician went to take the device out of the patient and the delivery system tip came off inside of the patients femoral artery just proximal of where percutaneous access was gained in the right groin.A clamp was successfully used to retrieve the delivery system tip.A selective angiogram was done to confirm that the artery was not damaged and perclose was used to close the artery." patient outcome: "patient doing well throughout procedure, during event & 24 hours post procedure.".
 
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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 Key7584435
MDR Text Key110924573
Report Number2247858-2018-00136
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 company representative
Type of Report Initial,Followup
Report Date 09/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/17/2021
Device Catalogue Number28-M340195362590U
Device Lot Number170522174
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/14/2018
Initial Date FDA Received06/08/2018
Supplement Dates Manufacturer Received03/14/2018
Supplement Dates FDA Received09/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age56 YR
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