Model Number 800 |
Device Problems
Incomplete Coaptation (2507); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Mitral Regurgitation (1964)
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Event Date 04/11/2018 |
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 following the implant of this annuloplasty ring, after repairing the mitral valve and implanting the ring, echocardiogram revealed incomplete coaptation with mild regurgitation.Cardiopulmonary bypass (cpb) was re-initiated and the ring was explanted and replaced with a non-medtronic ring.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Product analysis: upon receipt at medtronic's quality laboratory, there was no evidence of distortion.Radiography showed no fractures in the ring nor any presence of calcification.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.There were no anomalies noted during analysis that may have contributed to the reported clinical observation.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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