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

Model Number 995

Device Problems Perivalvular Leak (1457); Structural Problem (2506); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Thrombosis (2100); Tricuspid Regurgitation (2112); Regurgitation (2259); Thromboembolism (2654)

Event Date 10/17/2013

Event Type  Death  

Manufacturer Narrative

Based on the content of the article, there was no information as to which devices were associated with the adverse events.A device history records review could not be performed, as the device serial numbers were not provided.Based on the limited information received, a root cause cannot be determined.

Event Description

Medtronic received information from a medical journal article examining long-term outcomes for 725 patients from a multi-center evaluation over a 15-year period that there were 28 valve-related deaths and 65 unexplained deaths associated with different sizes of this aortic bioprosthetic root.The valve-related deaths were attributable to thromboembolism in 8 patients, endocarditis in 6, antithromboembolic-related major hemorrhage in 3, structural valve deterioration (svd) in 3, aortic regurgitation in 5 (central in 2, paraprosthetic in 2, and indeterminate in 1), thrombosis in 1, nonstructural dysfunction in 1, and severe aortic stenosis with mitral and tricuspid regurgitation in 1.The patient study population included 725 patients for whom follow-up was achieved for post-implant time periods ranging from zero to 18 years, with a median of 7.8 years.The average demographics of the cohort at device implant were 72 years of age (range 36-91) and 55% male.The study included patients from eight centers, with six of the eight centers continuing to collect clinical outcomes data after ten years.

Manufacturer Narrative

Additional information has been requested from the article's author contact.Without device-identifying information, medtronic¿s database could not be searched to determine if any of these events were previously reported.A separate report has been filed for structural valve deterioration and procedure-related serious injuries reported in the article.The reported event date is the date the article was published online.The reported death date was chosen on the basis of the end of the data collection, december 2011.(b)(4).Long-term clinical outcomes 15 years after aortic valve replacement with the freestyle stentless aortic bioprosthesis authors: david s.Bach, md, and neal d.Kon, md annals of thoracic surgery february 2014, vol.97, issue 2, pp.544-551 published online oct.17, 2013 http://dx.Doi.Org/10.1016/j.Athoracsur.2013.08.047.

Manufacturer Narrative

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 VALVES DIVISION; 1851 e. deere ave.; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4111216
• MDR Text Key: 12549836
• Report Number: 2025587-2014-00688
• 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: Literature,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: No
• 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): Death; Required Intervention
• Patient Age: 00072 YR