PERFUSION SYSTEMS CRYOFLEX SURGICAL ABLATION PROBE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
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Model Number 60SF3 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Arrhythmia (1721)
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Event Date 11/06/2023 |
Event Type
Injury
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Event Description
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The patient had a concomitant surgical procedure of mitral valve repair and tricuspid valve repair through sternotomy.During the same procedure a cryoflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by a cardioblate generator were used.The left atrial appendage was amputated/excised and oversewn.The left pulmonary vein (lpv) and right pulmonary vein (rpv) conduction blocks were not performed.The surgeon attempted to preform conduction block testing but was not able to do so as the patient was still in atrial fibrillation.The patient experienced new junctional rhythm after index procedure.The adverse event was deemed by the site as unlikely related to the cardioblate lp clamp and the study devices and possibly related to the cryoflex probe, the study procedure and the concomitant procedure.The rationale for possibly relating the adverse event to the concomitant procedure was due to the myocardial edema from lesions and due to myocardial edema from annular sutures.The rationale for unlikely relating the adverse event to the study device was due to myocardial edema from freeze lesion.The adverse event was deemed by the sponsor as related to the cryoflex probe, the cardioblate lp clamp, the concomitant procedure and the study procedure and not related to the cryoconsole.The outcome status of the patient is recovering/resolving.
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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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Manufacturer Narrative
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Additional information b7.Relevant history: atrial fibrillation, covid-19, hypertension, mitral insufficiency and tricuspid insufficiency.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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Manufacturer Narrative
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Additional information b5: the patient had a concomitant surgical procedure of mitral valve repair and tricuspid valve repair through sternotomy.During the same procedure on the a cryoflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by a cardioblate gene rator were used.The left atrial appendage was amputated/excised and oversewn.The left pulmonary vein (lpv) was not performed and the right pulmonary vein (rpv) conduction blocks was not achieved.The surgeon attempted to preform conduction block testing but was not able to do so as the patient was still in atrial fibrillation.The patient experienced new junctional rhythm after index procedure.The adverse event was deemed by the site as unlikely related to the cardioblate lp clamp and the study devices and possibly related to the cryoflex probe, the study procedure and the concomitant procedure.The rationale for possibly relating the adverse event to the concomitant procedure was due to the myocardial edema from lesions and due to myocardial edema from annular sutures.The rationale for unlikely relating the adverse event to the study device was due to myocardial edema from freeze lesion.The adverse event was deemed by the sponsor as related to the cryoflex probe, the cardioblate lp clamp, the concomitant procedure and the study procedure and not related to the cryoconsole.The outcome status of the patient is recovering/resolving.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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Manufacturer Narrative
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Correction b1: updated to adverse event correction b2: updated to other correction h1 type of reportable event: serious injury.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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