Model Number 690R |
Device Problem
Bent (1059)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/05/2016 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the product specimen has not been returned for device evaluation.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.
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Event Description
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Medtronic received information that immediately following implant of this annuloplasty ring, it was explanted and replaced due to a bend at the anterior limb of the ring digging into the torus-aorticus.The health care professional believed there was chance that with repeated contraction, it could have perforated the right atrium or aorta.No 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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