Catalog Number 28-B2-26-100S |
Device Problems
Fluid/Blood Leak (1250); Material Invagination (1336)
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Patient Problems
Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/06/2022 |
Event Type
malfunction
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Event Description
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"device: treo.Catalogue number: pending.Surgeon: (b)(6).Implant date: (b)(6) 2022.Description of event: kinking of stent with suspected moderate stenosis at left a.Iliaca adverse event start date: (b)(6) 2022.Was the adverse event serious? yes.Related to procedure: related.Related to device: related to iliac leg.Anticipated/unanticipated event: anticipated.Adverse even outcome: reimplantation of a new stent graft.Recovered - (b)(6) 2022".Patient outcome - "after the procedure a type ii endoleak was observed (right iliac).Was resolved by balloon angioplasty.".
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Manufacturer Narrative
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This complaint was involved with three devices.Device 1 is being reported under this report, device 2 is being reported under mdr-2247858-2022-00084, and device 3 is being reported under mdr-2247858-2022-00085.
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Event Description
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"device: treo.Catalogue number: pending - see image below.Surgeon: aleksandar dimov.Implant date: (b)(6) 2022 description of event: kinking of stent with suspected moderate stenosis at left a.Iliaca adverse event start date: (b)(6) 2022.Was the adverse event serious? yes.Related to procedure: related.Related to device: related to iliac leg.Anticipated/unanticipated event: anticipated.Adverse even outcome: reimplantation of a new stent graft (details attached for reintervention) recovered - (b)(6) 2022." patient outcome - "after the procedure a type ii endoleak was observed (right iliac).Was resolved by balloon angioplasty.".
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Manufacturer Narrative
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This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2022-00083, device 2 is being reported under mdr-2247858-2022-00084, and device 3 is being reported under mdr-2247858-2022-00085.
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Search Alerts/Recalls
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