BOLTON MEDICAL, INC. TREO ABDOMINAL STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC
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Catalog Number 28-BC33B14014S1960 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2023 |
Event Type
malfunction
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Event Description
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"the device was stuck in the valve of the remaining ipsilateral sheath of the main body.It was not possible to pull out the device.The device could not be pulled over the valve of the remaining ipsilateral sheath of the main body.It was therefore necessary to change to a new sheath for the ipsilateral leg.There were no effects on the patient and the operation was still successful." patient outcome - "no effects on the patient.The remaining sheath of the main body and the stuck device were pulled out and the procedure was continued with a new dry seal sheath.".
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Manufacturer Narrative
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Bolton medical is voluntarily reporting an event related to a treo custom-made device.Custom made treo devices are not marketed in the us, however they are similar to the treo abdominal stent-graft system approved for sale in the us ((b)(4).).The event occurred in germany.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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Manufacturer Narrative
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Bolton medical is voluntarily reporting an event related to a treo custom-made device.Custom made treo devices are not marketed in the us, however they are similar to the treo abdominal stent-graft system approved for sale in the us (p190015).The event occurred in germany.Section h has been updated following completion of the investigation.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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"the device was stuck in the valve of the remaining ipsilateral sheath of the main body.It was not possible to pull out the device.The device could not be pulled over the valve of the remaining ipsilateral sheath of the main body.It was therefore necessary to change to a new sheath for the ipsilateral leg.There were no effects on the patient and the operation was still successful." patient outcome - "no effects on the patient.The remaining sheath of the main body and the stuck device were pulled out and the procedure was continued with a new dry seal sheath.".
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Search Alerts/Recalls
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