Catalog Number RONYX30034JX |
Device Problems
Burst Container or Vessel (1074); Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2022 |
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 two resolute onyx rx coronary drug eluting stents to treat a lesion with chronic complete occlusion-100% (cto) in the left anterior descending branch (lad).The devices were inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated with a 2.0mm non-mdt device.The devices did not pass through a previously deployed stent.It was stated that there was some calcification observed but it was not difficult to insert the devices.It was reported that there were expansion difficulties during stent placement.The balloons would not inflate at all and the devices were removed.It was stated that a little bit of resistance was felt when pulling the devices.It was stated that no tearing was noted on the device outside the body.A non-medtronic stent was then placed using a non-medtronic guide extension catheter.No injury was reported.
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Manufacturer Narrative
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Additional information: the ivus image review failed to identify a reason for the failure of the balloon to inflate on this occasion.No evidence of extensive/severe calcification was observed.There are some eccentric calcification noted in the small lumen that was examined by ivus.A few small branches pop up.The fact that there was no resistance in passing through the lesion but some encountered on retrieval may indicate some possible residual balloon inflation.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: an attempt was made to use two resolute onyx rx coronary drug eluting stents to treat a lesion with almost no tortuosity/bending.No resistance noted while advancing the devices to the lesion and the device got to the lesion smoothly.The inflation pressure (atm) was gradually raised to nominal pressure of 12 atm when it was determined that there were inflation difficulties.The same inflation device was used successfully to expand the non mdt stent without any issues.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.A kink was evident on the hypotube.A tear was evident to the guide wire entry port of the exchange joint.The stent was positioned on the balloon between the marker bands as per specifications.No deformation evident to the stent.The balloon passed negative prep.On pressurisation of the device, liquid was observed exiting the proximal of the balloon proximal to the stent.The balloon failed to inflate; the stent failed to deploy.Upon visual inspection of the device, there was a short longitudinal tear on the balloon material proximal to the stent.The balloon material was jagged and uneven at the tear site.No deformation evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.No other damage evident to the remainder of the device.Correction: device return date 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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