Catalog Number 28-M330155302290U |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problems
Death (1802); Occlusion (1984)
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Event Date 12/16/2020 |
Event Type
Death
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Manufacturer Narrative
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This complaint was involved in two devices.Device 1 is being reported under mdr 2247858-2021-00008.Device 2 is being reported under mdr 2247858-2021-00009.
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Event Description
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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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Manufacturer Narrative
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This complaint was involved in two devices.Device 2 is being reported under mdr 2247858-2021-00009.
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Event Description
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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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Search Alerts/Recalls
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