Catalog Number RONYX40015JX |
Device Problem
Material Deformation (2976)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/29/2022 |
Event Type
Injury
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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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One resolute onyx coronary drug eluting stent was attempted to be used to treat a mildly calcified lesion with mild flexion and 75% stenosis located in the proximal left anterior descending branch (lad).The device was inspected before use with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.It was reported that stent deformation occurred in vivo during positioning of the stent.The stent length extended from 15mm to 23mm.The stent was noted to be deformed after it had been implanted and was explanted.The stent was crimped to the blood vessel wall.The procedure was completed using another resolute onyx stent.No patient injury was reported.
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Manufacturer Narrative
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Additional information: fluoroscopic and oct procedural images were provided for review.The images show the delivery and deployment of what appears to be the 15mm stent in the lm/proximal lad.This stent was post dilated with a shorter balloon and kissing balloon inflation occurred in the lm/proximal lad with the lcx.These images do not show any difference in stent length or movement on the proximal end of the stent.A definite cause of the stent elongation cannot be identified from the images.Annex d code added.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 reported that stent deformation occurred in vivo after the stent was implanted.When the stent was checked after implantation using optical coherence tomography, (oct), it was noted that the distal edge was in the place as it was planned to be, but the proximal edge was elongated 5mm from the left main trunk (lmt).The stent was not explanted and remains inside the patient.No intervention was attempted to try and remove the deformed stent.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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