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

Model Number 60SF3

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

Patient Problems Anemia (1706); Pericardial Effusion (3271)

Event Date 08/09/2021

Event Type  Death  

Manufacturer Narrative

The device will not be returned for analysis as it was discarded.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient had a concomitant surgical procedure of mitral valve repair through a minimally invasive thoracotomy.During the same procedure a cryoflex probe and a cardioblate lp ft clamp were used.The left atrial appendage was successfully sutured closed.Left pulmonary vein (lpv) conduction block was not performed (could not access via thoracotomy) and right pulmonary vein (rpv) conduction block was successfully achieved.Five days post index procedure, the patient experienced anemia (low hemoglobin), which was treated with prolonged hospitalization and a blood transfusion.The adverse event was deemed by the site as not related to the study device or to the study procedure and causally related to the concomitant procedure.The clinical events committee (cec) deemed the event as possibly related to the study devices and causally related to the study procedure and to the concomitant procedure.

Manufacturer Narrative

Additional information: the adverse event was deemed by the site as not related to the study device, causally related to the study procedure and possibly related to the concomitant 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

Medtronic received additional information that the sponsor commented that the 1st passed cec results.Per cec the pericardial effusion tamponade led to death and was possibly related to the device.During post procedure the pericardial bleed was >40 transfusions.The temporal relationship to the catheter for the procedure.The 2nd pass cec results were reviewed.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 possibly related to the cardioblate lp and cryoflex study devices and study procedure, causally related to the concomitant procedure and not related to the ft-10 generator and cryoconsole.The site provided the following rationale for relating the adverse event to the concomitant procedure; risk of post-op complications, but it could possibly have a causal relationship to the study procedure and could possibly be related to concomitant procedure.The site provided the following rationale for relating the adverse event to the cryoflex probe and cardioblate lp device; blood loss is a known risk for these devices.Medtronic received additional information that the cec deemed that the event was not related to the cryoconsole and ft-10 generator.It was stated that non-sudden cardiac death occurred.It was stated that pericardial effusion led to death.Correction b5: during the same procedure on ((b)(6) 2021) a cryoflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by a ft-10 generator were used.The left atrial appendage was successfully sutured closed.Correction g4.4 (pma / 510(k) #): this field has been updated.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 adverse event was deemed by the cec as possibly related to the study procedure and the concomitant 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.

• Brand Name: CRYOFLEX SURGICAL ABLATION PROBE
• 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: 12703338
• MDR Text Key: 278529145
• Report Number: 3008592544-2021-00040
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 00763000114626
• UDI-Public: 00763000114626
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123733
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 60SF3
• Device Catalogue Number: 60SF3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2021
• 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): Hospitalization; Required Intervention; Death
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 126 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White