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Model Number TRCR25022X |
Device Problems
Detachment of Device or Device Component (2907); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2024 |
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 trucor coronary drug eluting stent to treat a lesion with 98% calcification, no tortuosity and 80% stenosis in segment 7 of the left anterior descending (lad) artery.There were no issues with the product when removing it from the packaging.The device was not inspected.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not noted while advancing the device.Excessive force was not used.It was reported that the device or component detached, cracked, or fractured.It was stated that the catheter/delivery system deformed.During the procedure it was noted that on the second third of the stent, the strut had popped up and the stent was removed. the strut had been noted to be damaged while try ing to position the stents at the lesion.The product was not bent during or before use. the procedure was completed with a non medtronic stent.The patients condition at the time of the procedure was reported to be good.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: initial full name, address and phone number.Product analysis: the device was received for analysis.No detachment was evident to the device.The stent was positioned on the balloon between the marker bands as per position specification, but due to mid stent deformation the stent did not meet visual acceptance specification.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.No other damage was 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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Manufacturer Narrative
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Additional information: initial reporters first name.Annex d codes added.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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