Model Number TRCR30038X |
Device Problems
Material Deformation (2976); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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An attempt was made to use one onyx trucor coronary drug eluting stent to treat a lesion. it was reported that stent deformation occurred in vivo during positioning/advancement.It was stated that the stent couldn¿t pass through the lesion.The patient is alive with no injury.Please note that this device (onyx trucor) is not marketed in the united states; however, the device is deemed the same as the united states marketed device (resolute onyx rx).
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Manufacturer Narrative
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Additional information: the lesion had 20-degree tortuosity, 30% calcification and 95% stenosis and was located in the right coronary artery (rca). there were no problems detected when the device was removed from the tray.The lesion was pre-dilated.The device did not pass through a previously placed stent.Resistance was encountered while advancing the device.Excessive force was not used.The stent was damaged while attempting to be passed through the lesion.The device was replaced with another medtronic product of the same size.Patient demographics section a.Patient information.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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