BOLTON MEDICAL, INC. TREO ABDOMINAL STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC
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Catalog Number 28-B2-30-100 |
Device Problems
Migration (4003); Ejection Problem (4009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Event Description
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"standard infrarenal device deployed as per ifu.Unable to deploy nosecone and release stent-graft from deployment system after unsheathing the stent-graft.Had to deploy bailout as per ifu (12 bail out technique - page 74/77).Due to significant traction / counter traction needed, device deployed covering both renal arteries.Chimney stent placed in both renal arteries successfully." patient outcome - "longer procedure down and conversion of standard evar into a chimney evar and its long-term durability.".
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Manufacturer Narrative
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Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Event Description
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"standard infrarenal device deployed as per ifu.Unable to deploy nosecone and release stent-graft from deployment system after unsheathing the stent-graft.Had to deploy bailout as per ifu (12 bail out technique - page 74/77).Due to significant traction / counter traction needed, device deployed covering both renal arteries.Chimney stent placed in both renal arteries successfully.".Patient outcome - "longer procedure down and conversion of standard evar into a chimney evar and its long-term durability.".
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Search Alerts/Recalls
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