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Model Number RSINT30015X |
Device Problems
Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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An attempt was made to use two resolute integrity rx coronary drug eluting stents (des) to treat a lesion in the right coronary artery (rca).The devices were inspected with no issues noted.The 3.00x15mm resolute integrity device passed through a previously-deployed stent.Resistance was encountered when advancing the devices.Excessive force was not used during delivery.It was reported that the stent malfunctioned after detaching from the balloon catheter. it was detailed that during the guide wire's journey, the 2.50x30mm resolute integrity stent detached from the balloon catheter while attempting to advance.When the 3.00x15mm resolute integrity device was then advanced, it too detached from the balloon catheter.There was no medical or surgical intervention needed to prevent a permanent impairment of a function.The event did not lead to or extend patient hospitalization.The patient is alive with no injury.
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Manufacturer Narrative
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Additional information: it was later reported that both stents dislodged in vivo.The 3.00x15mm resolute integrity stent did not remain in the vessel.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.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.
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Manufacturer Narrative
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Product analysis: the device was returned for analysis.Device returned with an unknown non-medtronic device that was cut.Kinks were evident on the hypo-tube.The transition shaft was stretched along its length.A kink was evident on the distal shaft.The stent was not present on the balloon and did not return for analysis.The non-medtronic device was placed in the water bath to flush for presence of stent.After flushing the non-medtronic device, the stent was not located.Blood was visible under the folds of the balloon.The balloon folds remained intact.Crimp impressions were visible on the exposed balloon surface.No deformation was evident to the distal shaft.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood/deformation in the guidewire lumen.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.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.
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Search Alerts/Recalls
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