Model Number 900 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 11/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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Additional information has been requested, but no new information has been received to date.The device has not been received for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.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 following implant of this annuloplasty ring in the tricuspid position, this ring was explanted and replaced with a smaller sized ring.No failure mode and no other adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received additional information that this rings was explanted because the surgeon was not satisfied with the repair, believing that the chosen ring was of the incorrect size.No significant regurgitation was noticed while testing the valve after the rings were placed however the surgeon was not satisfied with valve coaptation, so a smaller size was used.There were no other adverse effects to the patient.
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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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