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Model Number ONYXNG22538UX |
Device Problems
Fracture (1260); 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 10/13/2023 |
Event Type
malfunction
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Event Description
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It was intended to use one onyx frontier coronary drug-eluting stent (des) to treat a lesion.There was no damage noted to the packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with issues noted.Negative prep was not performed.It was reported that the stent came off the balloon as the stylet was being removed.The stent was fractured and cracked.It cannot be confirmed if this occurred during removal of the stylet.It was not realized that the stent was absent until attempting to deploy the delivery system.The balloon from the stent delivery system was inflated and deflated, then the balloon was pulled back.A coronary angiogram was performed to assess the stent implantation.It was at this point it was noted that there was no stent deployment or implantation.The stent was found on the stylet and had never been introduced into the patient¿s vasculature.No patient injury was reported.No complications or adverse effects were reported from the event.
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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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Manufacturer Narrative
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Product analysis: the device was returned for analysis.The device returned with a kink on the hypo-tube.The stent returned on the stylette.There was a kink evident on the core wire and a kink on the distal shaft.The balloon folds remained intact.Crimp impressions were visible on the exposed balloon surface.There was no damage to the distal tip.There was deformation evident to the dislodged stent with struts stretched and raised.The inner lumen patency was verified with a mandrel.No other damage evident to the remainder of the device.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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