MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOCONSOLE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING

Model Number R65CS1

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

Patient Problem Shock (2072)

Event Date 07/08/2022

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

The patient had a concomitant surgical procedure of septal myectomy and papillary muscle resection through sternotomy.During the same procedure on ((b)(6) 2022) a cryoflex probe powered by a cryoconsole, and a cardioblate lp ft clamp powered by a ft-10 generator were used.The left atrial appendage was closed.Left pulmonary vein (lpv) was conduction block was not performed as the patient was in congenital heart block (chb) with pacemaker.It was stated that it was very difficult to see exit block.Right pulmonary vein (rpv) conduction block was achieved.On the (b)(6) 2022 the patient experienced shock.The patient was treated with a treated with blood transfusion and concomitant/additional medication was given.The patient had increasing vasopressor requirements after extubation.The patient¿s cardiac index was at 1.1.Worsening acidosis.The patient had acute kidney injury with elevated creatinine and urinary output (uop) less than 5 cc/hr.The patient had acute liver injury with elevated bilirubin, alanine transaminase (alt), aspartate aminotransferase (ast) and decreased level of conscious (loc).The patient was reintubated.Bicarb and fluids were given.Transesophageal echocardiogram (tee) was unchanged from intra-op.Veno-arterial extra corporeal membrane oxygenation (va ecmo) was initiated.Following va-ecmo, acidosis normalized, and lactate was trending down.Creatinine was trending down with increased uop.Bilirubin remained elevated.Ast/ast were decreasing.The patient was sedated and vented.On (b)(6) 2022 uop was back down.Continuous renal replacement therapy (crrt) via ecmo circuit was initiated.On the (b)(6) 2022 the patient was sent to the operating room for ecmo reconfiguration.The patient was unable to tolerate veno-veno (vv)-ecmo.The patient was returned to va-ecmo.On the (b)(6) 2022 the patient was returned to the operating room for ecmo revision.The patient was converted to central ecmo.On the (b)(6) 2022 the ecmo was weaned off.The patient had a non-sudden cardiac death on the (b)(6) 2022.The adverse event was deemed by the site as possibly related to the concomitant procedure and not related to the study procedure or devices.The rationale provided for the possible relationship to the concomitant procedure is possible relation to the stress of surgery and cardiopulmonary bypass.The adverse event was deemed by the sponsor as related to the concomitant procedure, study procedure and all of the study devices.The clinical events committee (cec) deemed the adverse event possibly related to the cryoflex probe, cryo-console instrument, the cardioblate lp ft clamp and the ft-10 generator.The cec deemed the adverse event as casually related to the concomitant and study procedures.The cec deemed that the adverse event led to the 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.

Manufacturer Narrative

Additional information b5: medtronic received additional information that comments from the cec assessment stated that there was immediate decompensation after the procedure and complications leading to death, that can not rule out the possible relationship to the 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.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 comments from the cec assessment stated that the death is non-sudden cardiac, the patient died of cardiogenic shock as a complication of index surgery.The adverse event was deemed by the site as possibly related to the concomitant procedure and not related to 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.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: CRYOCONSOLE
• Type of Device: SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15402701
• MDR Text Key: 299697346
• Report Number: 3008592544-2022-00053
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121878
• 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
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: R65CS1
• Device Catalogue Number: R65CS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Date Device Manufactured: 12/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White