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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ischemia (1942); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)
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Event Date 10/11/2022 |
Event Type
Injury
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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.
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Event Description
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Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the export advance and export ap aspiration catheters.Survey results are from an interventional cardiology in practice 15 years.In the past two months the physician has used export ap aspiration catheters.The physician uses approximately 10 export ap devices in an average month.During one procedure one export ap aspiration catheter was being used for infusion or delivery of diagnostic or therapeutic fluids.The device was used as it is described in the ifu.It was reported that one myocardial infarction/ischemia and one coronary or bypass graft thrombosis occurred.Both the myocardial infarction/ischemia and graft thrombosis were related to the procedure but not directly to the device itself.The adverse events did not require intervention.It was also reported that a kink occurred in vivo.The kink did not require intervention.The device performed successfully in its ability to deliver the aspiration catheter to the target lesion, and selectively infuse or deliver diagnostic or therapeutic fluids.No further patient injury was reported.
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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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Search Alerts/Recalls
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