Catalog Number RONYX27522X |
Device Problem
Burst Container or Vessel (1074)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/23/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
An attempt was made to use a resolute onyx coronary drug eluting stent to treat a moderately tortuous, moderately calcified lesion in the mid circumflex (cx) artery.There was no damage noted to the device packaging.There were no issues noted when removing the device from the protective hoop.The device was inspected with no issues noted.The lesion was pre-dilated.Resistance was not noted while advancing the device to the lesion.It was reported that a balloon rupture occurred at 4 atm during stent deployment.The stent was deployed after which the balloon rupture was noted.Around 3 to 4 inflations were performed prior to the issue occurring.The balloon was fully removed from the patient with the support of the guide catheter and the ptca wires.Post dilation of the stent with additional balloons was not required, the procedure was complete.The patient was reported alive with no injury.
|
|
Manufacturer Narrative
|
Additional information: the device was not moved or repositioned in the lesion while inflated.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: images reviewed shows the deployment of three stents, one in the lad, lcx and the final one in the rca.Pre dilations of the lesions were carried out and no issues were encountered during stent deployment.No evidence of a balloon burst was identified in the images received.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
|
|