Model Number 680R28 |
Device Problems
Perivalvular Leak (1457); Insufficient Information (3190)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 07/31/2018 |
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 this 28mm mitral annuloplasty ring was implanted and explanted during the same procedure for unknown reasons.It was successfully replaced with a 29mm mitral bioprosthetic valve.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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Medtronic received additional information that the 28 mm mitral annuloplasty ring was fully sutured into place and the physician noted there was a leak, so the decision was made to remove the ring and implant a mitral bioprosthetic valve in its place.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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