MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE
|
Back to Search Results |
|
Model Number 995 |
Device Problems
Perivalvular Leak (1457); Structural Problem (2506); Insufficient Information (3190)
|
Patient Problems
Aortic Regurgitation (1716); Endocarditis (1834); No Information (3190)
|
Event Date 10/17/2013 |
Event Type
Injury
|
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 52 cases of reoperation due to structural valve deterioration associated with different sizes of this aortic bioprosthetic root.Of the 52 reoperations, 47 resulted in explant of the bioprosthesis.Reoperations were attributable to svd in 31 patients, endocarditis in 10, aortic regurgitation in 9 (paraprosthetic in 7, combined central and paraprosthetic in 1, and indeterminate in 1), and nonstructural dysfunction in 2.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.This is the second of two reports regarding this journal article.A separate report has been filed for deaths listed in the article.The reported event date is the date the article was published online.(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
|
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.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|