Model Number 638BL |
Device Problems
Occlusion Within Device (1423); Insufficient Information (3190)
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Patient Problems
Stenosis (2263); 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.The bioprosthetic valve was subsequently explanted and replaced with a bioprosthetic valve of the same model.No additional adverse patient effects were reported. added weight and updated patient and 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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