Model Number 638R |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Insufficiency, Valvular (1926)
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Event Date 09/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.
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Event Description
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Medtronic received information that after this annuloplasty ring was sutured into place, the patient's leaflets would not coapt properly.The physician determined that the device was the incorrect size for the patient.The device was explanted and replaced with a bioprosthetic valve during the same procedure.No further adverse patient effects were reported.
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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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