Model Number 700FF35 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
No Information (3190); No Code Available (3191)
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Event Date 08/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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Medtronic received information that immediately post implant of this 35mm mitral annuloplasty band, it was explanted and replaced with a 39mm annuloplasty band of the same model.The reason for replacement was not reported.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received additional information that the 35mm band was too small for the patient's annulus, subsequently resulting in systolic anterior motion of the mitral valve.There was no allegation against the 35mm band itself.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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