MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number AFAPRO28

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Air Embolism (1697); Stroke/CVA (1770); Dyspnea (1816); Fever (1858); Necrosis (1971); Sepsis (2067); Convulsion/Seizure (4406); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/17/2023

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

It was reported that during a cryo ablation procedure, damage occurred to the left posterior atrial wall next to the left superior pulmonary vein (lspv).The case was completed with cryo.There was also suspect that there could be damage to the esophagus. the esophagus was checked from inside through gastroscopy and found in good condition.The patient had polymicrobial sepsis with a suspected abscess in the mediastinum.Additionally, the patient had a cerebrovascular accident (cva).A computerized tomography (ct) was performed and air/gas bubbles were observed.The patient had surgery at a later time to repair the posterior wall and a pericardial patch was inserted.The patient was hospitalized. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: product id: 990063-020, product type: mapping catheter; product id: 4fc12, product type: sheath.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

B3: it was reported the patient expired on either (b)(6), 2023, or (b)(6), 2023.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.

Event Description

It was later reported that the patient was discharged from the hospital ten weeks after the procedure.The patient expired two or three days after discharge.

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.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

It was reported that during a cryo ablation procedure, damage occurred to the left posterior atrial wall next to the left superior pulmonary vein (lspv).The case was completed with cryo.There was also suspect that there could be damage to the esophagus. the esophagus was checked from inside through gastroscopy and found in good condition.The patient had polymicrobial sepsis with a suspected abscess in the mediastinum.Additionally, the patient had a cerebrovascular accident (cva).A computerized tomography (ct) was performed and air/gas bubbles were observed.The patient had surgery at a later time to repair the posterior wall and a pericardial patch was inserted.The patient was hospitalized. no further patient complications have been reported as a result of this event.2023-10-03: it was later reported that ten days after the cryo ablation procedure, the patient returned to the hospital with a fever and bacteremia.The patient was given antibiotics.Approximately two weeks after the antibiotic treatment and surgery to patch the posterior wall, the patient underwent a second additional surgery to treat the abscess, but it remained unresolved.During that surgery, a laceration and tiny hole were found in the esophagus.It was also reported that necrosis or gangrene was found between the left superior pulmonary vein (lspv) and left inferior pulmonary vein (lipv).The patient remains hospitalized for further "conservative" treatment of the unsolved abscess.(b)(6) 2023: it was later reported that the patient was discharged from the hospital ten weeks after the procedure.The patient expired two or three days after discharge.2023-12-05: additional information was received indicating that it was surmised that the cause of death was sepsis and that the earlier mentioned "tiny hole/laceration" was an atrio-esophageal fistula.No further information is available.

Manufacturer Narrative

Product event summary: the data file was returned and analyzed.The patient file showed 20 applications were performed using catheter identified as afapro28/18846.The patient file didn't show any system notice on the reported date of the event.In conclusion, the reported clinical issues occurred during the procedure.There is no indication of a relationship of the adverse events to the performance or malfunction of the product from analysis of the data files.The physical product was not returned for analysis.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

2023-10-03: it was later reported that ten days after the cryo ablation procedure, the patient returned to the hospital with a fever and bacteremia.The patient was given antibiotics.Approximately two weeks after the antibiotic treatment and surgery to patch the posterior wall, the patient underwent a second additional surgery to treat the abscess, but it remained unresolved.During that surgery, a laceration and tiny hole were found in the esophagus.It was also reported that necrosis or gangrene was found between the left superior pulmonary vein (lspv) and left inferior pulmonary vein (lipv).The patient remains hospitalized for further "conservative" treatment of the unsolved abscess.

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

Additional information was received and indicated some of the treatment the patient had a significant decrease in function after the stroke and also had a seizure.Diagnostics and treatment details included laparoscopy for the esophageal hole, transesophageal echocardiogram through the esophagus, gastroscopy of the esophageal opening with a clip and stent placed then later removed for bleeding, an endoscopy was performed for the fistula, a magnetic resonance imaging (mri) of the brain with findings consistent with hypoxic damage, an electroencephalogram showed no evidence of epileptic activity, echocardiogram to assess the left ventricular function and no valvular disturbances were noted, the patient was also intubated due to shortness of breath and a conscious decline, and a tracheostomy performed.

• Brand Name: ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17785130
• MDR Text Key: 323875319
• Report Number: 3002648230-2023-00440
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P100010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 18846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Death; Hospitalization; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 80 KG