MEDTRONIC, INC. CRYOCONSOLE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
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Model Number 65CS1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Heart Block (4444)
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Event Date 11/08/2023 |
Event Type
malfunction
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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 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 block were 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 complete heart block after index procedure.The adverse event was deemed by the site as unlikely related to the study procedure, the concomitant procedure and the study devices.The rationale for unlikely relating to the study device and concomitant procedure was because the lesions were not in the proximity of the av node.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 right pulmonary vein (rpv) conduction block 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 complete heart block after index procedure.The adverse event was deemed by the site as unlikely related to the study procedure, the concomitant procedure and the study devices.The rationale for unlikely relating to the study device and concomitant procedure was because the lesions were not in the proximity of the av node.The outcome status of the patient is recovering/resolving correction: additional review of the event and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803 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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