Model Number ONYXNG22534UX |
Device Problems
Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/21/2023 |
Event Type
Injury
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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An attempt was made to use one onyx frontier coronary drug eluting stent to treat a mildly tortuous lesion in the ostium of the left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The device passed through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that stent dislodgement occurred during delivery to/at the lesion.The stent got stuck in the left main (lm) stent.When it was attempted to extract the dislodged device, the stent broke.The detached portion was extracted separately.Everything was removed via a snare.No further patient injury was reported.
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Manufacturer Narrative
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Additional information: the lesion being treated was mildly calcified with 70-80% stenosis.The lesion was predilated with a 2.25 balloon.The device was not kinked and re-straightened during use.The stent became stuck in a 3.0 x 26 onyx frontier stent (pli20)which had been previously implanted in the circumflex into the left main.The stent would not advance or come back.This caused the stent to dislodge.Resistance was noted during withdrawal of the device and excessive force was used.No damage was caused to the previously deployed stent.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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