Model Number ONYXNG35038UX |
Device Problems
Premature Activation (1484); Use of Device Problem (1670)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/12/2023 |
Event Type
malfunction
|
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.
|
|
Event Description
|
An attempt was made to use one onyx frontier coronary drug eluting stent to treat a mildly tortuous, mildly calcified lesion in the mid right coronary artery (rca).The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that when the stent was delivered to the lesion it was noticed under fluoroscopy that each marker band had a circle or lightbulb effect, appearing like the balloon was inflated.It was detailed that the indeflator was not connected and no air was used in the catheter at that stage.The stent was removed and another stent of the same size was inserted and deployed.The patient is alive with no injury.
|
|
Manufacturer Narrative
|
Additional information: annex d codes.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
|
Product analysis: fluoroscopic image confirms the presence of the device in the rca with contrast injection into the vessel.The phenomena described by the account as a lightbulb effect is confirmed.This appears to be due to the presence of air in the proximal and distal balloon pillows.Product analysis: the device was received for analysis.The stent was positioned on the balloon between the marker bands as per position specification.No deformation was evident to the stent wraps.The balloon folds were disturbed indicating the balloon had been partially inflated.It appeared the distal stent wraps were partially expanded.Proximal stent od = ( 0.046 inches); mid stent od = ( 0.040 inches ); distal stent od = (0.049inches).Specification = ( 0,055 inches) max.The od measurements indicate that partial deployment had occurred.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.Additional information: the packaging of the device was intact and undamaged prior to opening.There was no difficulty removing the device from the hoop.There was no difficulty removing the protective sheath or the packaging stylette.An attempt was made to load the device onto a 0.014 non-medtronic guidewire.Initial reporter phone #.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
|
|