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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-M330095302290U
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problems Death (1802); Occlusion (1984)
Event Date 12/16/2020
Event Type  Death  
Manufacturer Narrative
This complaint was involved in two devices.Device 1 is being reported under mdr 2247858-2021-00008.Device 2 is being reported under (b)(4).
 
Event Description
A frozen elephant trunk was performed on this patient and the first relay plus was placed too distal but proximal to the visceral arteries.A second piece was placed more proximal and sewn to open graft.We did confirm through angio that visceral were not covered but did recognize that the two stent grafts were not connected.Decided to leave alone to let patient recover from open surgery and bridge in 30 days.The ct done on (b)(6) 2020 shows the aneurysm seems to have pressurized and smashed the proximal portion of the distal piece which occluded the descending aorta.Will attach pre case plan.Patient outcome - "patient expired on (b)(6) 2020 ".
 
Manufacturer Narrative
This complaint was involved in two devices.Device 1 is being reported under mdr 2247858-2021-00008.
 
Event Description
A frozen elephant trunk was performed on this patient and the first relay plus was placed too distal but proximal to the visceral arteries.A second piece was placed more proximal and sewn to open graft.We did confirm through angio that visceral were not covered but did recognize that the two stent grafts were not connected.Decided to leave alone to let patient recover from open surgery and bridge in 30 days.The ct done on (b)(6) 2020 shows the aneurysm seems to have pressurized and smashed the proximal portion of the distal piece which occluded the descending aorta.Will attach pre case plan.Patient outcome - "patient expired on (b)(6) 2020".
 
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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 Key11289363
MDR Text Key230668243
Report Number2247858-2021-00009
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 04/01/2021
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-M330095302290U
Device Lot Number2006230058
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/12/2021
Initial Date FDA Received02/05/2021
Supplement Dates Manufacturer Received01/12/2021
Supplement Dates FDA Received04/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age43 YR
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