Model Number ONYXNG25034UX |
Device Problems
Entrapment of Device (1212); Material Deformation (2976); Positioning Problem (3009)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/01/2023 |
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 lesion.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that the stent failed to cross the lesion and stent deformation occurred in vivo during positioning/advancement.It was believed that the wire was under the strut of a stent that had already been placed and when it was attempted to move forward to place the onyx frontier stent it would not go or cross.When the onyx frontier stent was pulled back, it was found that the end of the stent was deformed.Another same size onyx frontier stent was used to complete the procedure.No patient injury was reported.
|
|
Manufacturer Narrative
|
Image analysis: three image were provided of the distal section of the device.It appears deformation was evident to the stent wraps with struts stretched distally.Product analysis: the device was received for anlaysis.The stent was not positioned on the balloon between the marker bands as per position specification.The stent was stretched distally over the distal marker band.Due to the stent deformation, the stent did not meet visual acceptance specification.Deformation was evident to the distal stent wraps with struts stretched and raised.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.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
|
|