Catalog Number RSINT30030X |
Device Problem
Activation Problem (4042)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product analysis: a kink was evident to the hypotube.The stent returned on the balloon.Partial expansion of the proximal and distal stent wraps was evident, with mid stent wraps remaining intact on the balloon.A partial deployment of the stent had occurred.The balloon folds were partially opened.Crimp impressions were visible on the exposed balloon surface.It was not possible to confirm stent positioning due to the partial deployment.The expanded sections of the stent were flattened upon return.No deformation evident to the distal tip.The balloon was inflated to a nominal of 9atm with no issues noted, and the stent expanded with no issues noted.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.
|
|
Event Description
|
An attempt was made to use one resolute integrity coronary drug eluting stent to treat a moderately tortuous lesion.The device was inspected with no issues.It was reported that the stent failed to cross the calcified lesion. it was believed that the event was due to the use of the device in difficult lesion morphology/anatomy, i.E.The event was procedural related and not device related.The patient was reported to be alive with no injury.
|
|
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.
|
|
Search Alerts/Recalls
|
|