Catalog Number RSINT30026X |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 a resolute integrity coronary drug eluting stent to treat a severely calcified, mildly tortuous lesion with 80% stenosis located in the mid circumflex (cx) artery. the device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated. it was reported that stent deformation occurred in vivo during positioning.Stent placement did not occur and the procedure was abandoned. medical treatment will be continued.The patient is alive with no injury.
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Manufacturer Narrative
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Additional information: resistance was noted while advancing the device to the lesion.Excessive force was not used. it was further reported that the stent did not cross the lesion and became deformed.It is believed that the event was due to use of the device in difficult lesion morphology/anatomy, i.E.The event was procedural related and not device related.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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Device evaluation summary: device returned for evaluation.The stent was positioned on the balloon between the marker bands as per position specification, but due to proximal stent deformation the stent did not meet visual acceptance specification.Deformation was evident to the proximal stent wraps with struts raised.No deformation was evident to the distal tip.The inner lumen patency was verified with a mandrel.No other damage evident to the remainder of the device.Annex b, annex c, annex d codes added manufacturer details updated.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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