Catalog Number RSINT35026X |
Device Problems
Premature Activation (1484); Difficult to Remove (1528)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/22/2022 |
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 integrity rx coronary drug eluting stent to treat a mildly tortuous, severely calcified lesion with 60% stenosis in the proximal circumflex artery (cx).The device was inspected with no issues noted.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.It was reported that removal difficulties occurred prior to stent deployment.Patient is alive with no injury.
|
|
Manufacturer Narrative
|
Additional information: the stent was being removed prior to deployment as severe calcification was noted at the lesion entry point.The stent had not been expanded prior to the removal and the balloon was not opened while attempting to remove.No resistance was encountered as the device was retracted over the guidewire during removal.No damage was noted to the guidewire on removal from the patient.No stent deformation occurred as a result of the removal difficulties experienced.It was stated that the entire device was removed from the patient.A4: patient weight provided 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: a still image was returned for analysis.The still image provided was of a labelled shelf carton confirming the product size and lot number as reported from the field.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 summary: the stent was positioned on the balloon between the marker bands as per specifications.Balloon folds were disturbed, and proximal and distal stent wraps were slightly flared, indicating partial pressurisation/deployment occurred.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.A 0.014 inch guidewire was backloaded through the tip of the device, and advanced proximally through the guidewire entry port with no resistance 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.
|
|
Search Alerts/Recalls
|
|