Model Number RONYX27518JX |
Device Problems
Entrapment of Device (1212); Device Damaged by Another Device (2915); Material Deformation (2976); Positioning Problem (3009)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/06/2023 |
Event Type
malfunction
|
Event Description
|
An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a moderately tortuous, moderately calcified lesion with 100% chronic total occlusion (cto) in the proximal/mid/distal right coronary artery (rca).The device was not inspected prior to use.There was resistance/discomfort felt when delivering the stent.It was reported that the stent did not pass through the guide catheter to be delivered to the target lesion.The stent was removed from the guide catheter without any issues.When removed it was noted that the stent strut was partially deformed.The procedure was completed with a non-medtronic device.No patient injury was reported.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Image analysis: one still image was received for analysis.Image depicts a resolute onyx stent on the delivery system.Deformation is evident to the distal stent wraps with struts raised.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.
|
|
Manufacturer Narrative
|
Additional information: the device was inspected a little prior to use.The lesion was pre-dilated.It was later reported that the stent did not fail to exit the non-medtronic guide catheter at the target lesion.The stent failed to cross the lesion, and when the stent was checked it was noted that the balloon part at the tip was frayed.There were no detachments.The guide catheter was used successfully with other devices prior to the difficulties occur, and the same guide catheter was used to deliver the replacement device.Correction: facility phone number.Product analysis: the device was returned for analysis.The stent was not positioned on the balloon between the marker bands as per position specification.The distal stent wraps were stretched distally and positioned over the marker band.The proximal and mid stent wraps remained intact on the balloon.There was no evidence of stent displacement.Deformation was evident to the distal stent wraps with struts raised.Although the stent met od dimensional measurement criteria, stent deformation was confirmed based on the failed visual inspection.Deformation was 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.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.
|
|
Search Alerts/Recalls
|
|