MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number FR995-23

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Renal Failure (2041); Multiple Organ Failure (3261); Heart Block (4444); Respiratory Insufficiency (4462)

Event Date 11/17/2023

Event Type  Death  

Event Description

Medtronic received information that 9 days post implant of this 23mm aortic bioprosthetic valve, a permanent pacemaker was implanted, 8 days later the patient died. the reason for the permanent pacemaker was reported as third degree atrioventricular (av block), complete heart block (chb). the cause of death was not received.Therefore, relatedness of the death to the bioprosthetic valve could not be excluded.It is unknown whether an autopsy was performed.

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

Updated b5 updated b7 updated h6 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received additional information which indicated that a previously implanted pacemaker was explanted and replaced with a new permanent pacemaker 9 days post implant of this 23mm aortic bioprosthetic valve.It was also reported that there was a suspected postoperative sternotomy infection after valve implant for which exploration of the chest was performed during the pacemaker replacement procedure.It was noted that the patient experienced respiratory distress and continued heart failure after the pacemaker replacement procedure.The patient was then reintubated and had kidney failure and was started on continuous renal replacement therapy (crrt).It was reported that the patient developed pneumatosis intestinalis and underwent a exploratory laparotomy 16 days post implant of the valve.It was stated that the patient continued to suffer from worsening end organ dysfunction with multifactorial shock.It was reported that the patient died 17 days post implant of the valve.The cause of death was reported to be multiple organ failure with heart failure.No autopsy was performed.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18661188
• MDR Text Key: 334787728
• Report Number: 2025587-2024-00699
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FR995-23
• Device Catalogue Number: FR995-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Date Device Manufactured: 04/27/2023
• 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): Required Intervention; Hospitalization; Death
• Patient Age: 68 YR
• Patient Sex: Male