MAUDE Adverse Event Report: PERFUSION SYSTEMS CARDIOBLATE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING

Model Number 49341

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 04/19/2022

Event Type  Death  

Manufacturer Narrative

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.

Event Description

During the same procedure on ((b)(6) 2022) a cryoflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by an ft-10 generator were used.The left atrial appendage was sutured closed.Left pulmonary vein (lpv) and right pulmonary vein (rpv) conduction block were achieved.On ((b)(6) 2022) the patient experienced cardiac arrest and sudden cardiac death.The patient had pulseless electrical activity (pea) arrest.Cardiopulmonary resuscitation (cpr) was initiated and proper protocol was followed.Return of spontaneous circulation (rosc) was achieved but only for a short period of time.The patient went into ventricular fibrillation (vfib) arrest.The patient remained pulseless.The time of death of patient was then called.The adverse event was deemed by the site causally related to concomitant procedure and study procedure but not related to the study devices.The adverse event was deemed by the sponsor as related to concomitant procedure, study procedure and cryoconsole, cardioblate lp clamp and ft-10 generator study devices.The clinical events committee (cec) deemed causally related to concomitant procedure, study procedure and possibly related to all of the study devices.The cec determined the end point as non-event-sudden cardiac death and commented: procedure related death.

Manufacturer Narrative

Correction b5: the following text should have been at the start of b5 in the previous report.The patient had a concomitant surgical procedure of mitral valve replacement and coronary artery bypass grafting (cabg) with 4 anast omoses through sternotomy.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 b5: medtronic received additional information that the adverse event was deemed by the site as causally related to concomitant procedure, not related to the study procedure, and causally related to the cryoconsole, cryoflex probe, cardioblate lp clamp and ft-10 generator study devices.The sponsor updated their assessment of the adverse event as related to the cryoflex probe.Conclusion: based on the available information and review with the office of medical affairs, even though the assessment of the (cec) clinical events committee and the sponsor shows as possibly related to the medtronic devices.It is the opinion of this review that this event would be related to the concomitant procedure and study procedure with the death were not attributed to the medtronic product.There were no device malfunctions reported.Based upon this assessment, there are no new risks associated with the use of this device as no new failure modes or use conditions of the system have been observed.There have been no device discrepancies identified and therefore no product changes are necessary.Trends for issues with this device are monitored.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

Medtronic received additional information that the cause of death was mitral regurgitation and atrial fibrillation.Correction b5: the adverse event was deemed by the site causally related to concomitant procedure but not related to the study devices and study procedure.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.

Manufacturer Narrative

Additional information b5: the clinical events committee (cec) deemed not related to concomitant procedure, and study procedure, but related to all of the study devices.Medtronic received additional information that the cec provided the following comment: pea arrest.Medtronic received additional information that the adverse event was deemed by the sponsor as not related to the concomitant procedure, study procedure and study devices.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.

• Brand Name: CARDIOBLATE
• Type of Device: SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15586159
• MDR Text Key: 301548486
• Report Number: 2184009-2022-00269
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 00643169998018
• UDI-Public: 00643169998018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2022
• Device Model Number: 49341
• Device Catalogue Number: 49341
• Device Lot Number: 239D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Date Device Manufactured: 10/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White