Model Number 310C27 |
Device Problems
Perivalvular Leak (1457); Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 09/08/2017 |
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 9 years post implant of this 28 mm mitral annuloplasty band, the band was explanted and replaced with a 27 mm bioprosthetic valve due to unknown reasons.Immediately post implant of the replacement bioprosthetic valve, the valve was "explanted and wasted".The reason for explant 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 9 years post implant of this annuloplasty band, the band was explanted and replaced with a bioprosthetic valve due to stenosis.Immediately post implant of this bioprosthetic valve an echocardiogram revealed paravalvular leak (pvl).The bioprosthetic valve was subsequently explanted and replaced with a bioprosthetic valve of the same model.No additional adverse patient effects were reported. conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.A review of the device history record (dhr) was performed for this valve.This device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.Added weight and updated device code.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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