During a procedure, an attempt was made to use one resolute integrity rx coronary drug eluting stent to treat a lesion.It was reported that during advancement through the catheter, the device broke in the middle of the catheter.It was stated that a stent catheter fracture occurred in the middle of the stent catheter.The patient was reported to be alive with no injury.
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Additional information: the device was being used to treat a non-tortuous, very calcified lesion in the right coronary artery (rca) via a radial approach using a non-medtronic sheath.A non-medtronic guide catheter and guide wire were also used.The device was inspected before use with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Excessive force was used during delivery.It was later indicated that the stent could not pass the lesion with great friction being experienced.The stent was removed and the struts were observed to be open on the distal section of the stent.It was stated that there was no damage to the coronary artery.It was also indicated that the procedure was successfully completed using a 3.0 nc solarice balloon to dilate the lesion again and then a non-medtronic stent was implanted.Device evaluation summary: device returned for evaluation.Kinks were noted on the hypotube.There was a detachment on the hypotube 72cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.The stent was positioned on the balloon between the marker bands as per specifications.No deformation was evident to the stent.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.There was no other damage 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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