Model Number 620BG35 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Mitral Insufficiency (1963); Mitral Insufficiency (1963); Mitral Valve Prolapse (2471)
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Event Date 07/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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Medtronic received information that 5 years 9 months post implant of this 35mm mitral annuloplasty band, it was explanted and replaced due to severe mitral insufficiency from chronic myxomatous degeneration.A non medtronic device was successfully implanted in its place.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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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.
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Event Description
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Medtronic received information that 5 years 9 months post implant of this 35mm mitral annuloplasty band, it was explanted and replaced due to severe mitral insufficiency from chronic myxomatous degeneration.A non medtronic device was successfully implanted in its place.No additional adverse patient effects were reported. .
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Search Alerts/Recalls
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