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Model Number RONYX27534X |
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 01/15/2024 |
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 2.75x34mm resolute onyx coronary drug eluting stent to treat a moderately tortuous, moderately calcif ied lesion with 80% in the mid and distal right coronary artery (rca) and right posterior descending (r-pda) artery.The device was inspected with no issues noted.Negative prep was not performed.The device passed through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that stent deformation occurred in vivo during positioning/advancement.It was detailed that a guidewire was passed through a previously deployed stent in the mid rca segment to the distal lesion 80% extended to pda with ostial and proximal critical lesion. the stent failed to cross the previously deployed stent in the mid right coronary artery (rca) to cover the distal rca lesion.It was stated that the stent was pulled back and the stent strut deformed.The procedure was completed using a 2.5x30mm resolute onyx stent. the patient is alive with no injury.
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Manufacturer Narrative
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Additional information: the lesion was pre-dilated.It was detailed that the guidewire used was a non-medtronic guidewire.No issues were noted with the guidewire.The previously deployed stent in the mid rca was a medtronic stent. this device did not cause or contribute to the deformation of the resolute onyx stent, 2.75x34mm lot 0011645476.The procedure was completed using a 2.5x30mm resolute onyx stent with no issues noted.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: it was later reported that the ronyx27534x stent passed through the previously deployed stent.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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