Model Number 638BL28 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Mitral Regurgitation (1964); No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 05/21/2018 |
Event Type
Injury
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Manufacturer Narrative
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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.The ring was replaced with a 27mm bioprosthetic valve for unknown reasons.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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Medtronic received additional information that this 28mm mitral annuloplasty ring was implanted and explanted during the same procedure due to residual mitral regurgitation during inspection prior to closing the patients chest due to the patients native tissue.No additional adverse patient effects were reported. if information is provided in the future, a supplemental report will be issued.
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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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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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