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

Model Number FR995-25

Device Problems Material Rupture (1546); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)

Patient Problems Rupture (2208); Pseudoaneurysm (2605); Cusp Tear (2656); Valvular Insufficiency/ Regurgitation (4449)

Event Date 08/13/2020

Event Type  Death  

Event Description

Medtronic received information that 1 year and 9 months post implant of this 25 mm aortic root bioprosthesis, a pseudoaneurysm of the distal suture between the bioprosthetic valve and native aorta was reported.A dacron graft was placed to repair the pseudoaneurysm.Two months post repair, a pseudoaneurysm of the non-coronary cusp was reported.Two weeks later, a re-operation was performed to repair the pseudoaneurysm.One week post repair, the patient died.The cause of death was reported as rupture of the non-coronary sinus of valsalva with rhythm disorders.No autopsy was performed.

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic received additional information that 1 year and 9 months post implant of this 25 mm aortic root bioprosthesis, "the patient was hospitalized for an acute lung edema developed on a massive aortic leak due to aortic root deformation, secondary to a pseudoaneurysm of the distal anastomotic line".It was reported that operative findings highlighted a tear on the distal part of the valve wall, above the non-coronary sinus.The distal part of the valve was trimmed and a reconstruction of the sino-tubular junction was achieved using a dacron graft, strengthened by an extraluminal pericardial patch.Two months later, a ct scan highlighted a recurring pseudoaneurysm and the 25 mm bioprosthetic valve was explanted and replaced with a 23mm bioprosthetic valve of the same model.It was also reported that 1 week post explant of this 25mm aortic bioprosthetic valve, the patient died due to "harsh rhythmic problem".H6: codes 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 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: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 12753965
• MDR Text Key: 280509061
• Report Number: 2025587-2021-03347
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FR995-25
• Device Catalogue Number: FR995-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2022
• Date Device Manufactured: 11/05/2019
• 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): Hospitalization; Required Intervention; Death
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 76 KG