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Model Number ONYXNG35012UX |
Device Problems
Entrapment of Device (1212); Device Dislodged or Dislocated (2923); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/31/2023 |
Event Type
malfunction
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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 lesion.The device was not inspected before use.Negative prep was not performed.The lesion was pre-dilated.Resistance was encountered when pre-dilating.Resistance was not encountered when delivering the stent as a non-medtronic guide extension catheter (gec) was used after there was resistance when pre-dilating.Excessive force was not used.The device was not delivered through a previously deployed stent.It was reported that the stent dislodged from the delivery system while attempting to deliver the device to the lesion.When the stent was not viewed under fluoroscopy the delivery system was removed and there was no stent.The non-medtronic gec was removed, and the stent was found stuck on it.The dislodged stent was removed.There was no injury to the patient as a result of this event.
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Manufacturer Narrative
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Product analysis: the device was returned for analysis.The stent delivery system did not return for analysis.Only the dislodged stent returned.Deformation was evident to the stent with struts bunched.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.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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