Model Number MRCS38 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Information (3190)
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Event Date 06/13/2017 |
Event Type
Injury
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Manufacturer Narrative
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In the event narrative provided, the surgeon stated that he believed the event was a result of his suturing technique; however, the event will be investigated to exclude the possibility of a manufacturing deficit.Device not available for return.
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Event Description
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A memo-3d rechord annuloplasty ring was implanted on (b)(6) 2017.On (b)(6) 2017 dehiscence of the ring was identified, and the ring was explanted.The re-operation was performed without incident.
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Manufacturer Narrative
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(b)(4).However, based on the narrative provided, the user believed the failure was due to his suturing technique.As such, this event can reasonably be attributed to user error, and is therefore not device-related.
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Manufacturer Narrative
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On (b)(6) 2017, a complete manufacturing and material records review for the device was performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.As the device was not available for analysis, no further investigation could be conducted and the root cause of the event remains unknown.However, based on the review performed, no manufacturing deficits were detected.
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Search Alerts/Recalls
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