Model Number 9600TFX29A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
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Event Date 09/14/2021 |
Event Type
Injury
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Manufacturer Narrative
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At the time of this report, the information available does not reasonably suggest there was a malfunction of the edwards device or that the use or miss-use of the device caused or contributed to the event.To date, despite multiple requests for information, the patient medical records have not been received for review.A supplemental report will be submitted when and if additional information becomes available.In this case, the reason for explanting the 23mm sapien 3 thv 3 years and 11 months post tavr remains unknown and the device is not available for evaluation.There is no indication or allegation that a product deficiency or device malfunction contributed to the event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.This is one of two manufacturer reports being submitted for this case.
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Event Description
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As reported by patient implant registry department, approximately 3 years and 11 months post implantation of a 29mm sapien 3 valve in the mitral position the device was explanted and replaced with a surgical valve.The reason for the valve explantation is unknown at this time.
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Manufacturer Narrative
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Submitted supplemental in order to provide related case mfr #.Please reference related manufacturer report no: 2015691-2021-05579.
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Manufacturer Narrative
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A supplemental mdr is being submitted due to medical records findings.Per medical record review, the residual gradient across the valve was thought due to valve-in-valve (viv) prosthetic mismatch, despite multiple dilations.As such this mdr was reported in error and a corrected supplemental report is being submitted.
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Search Alerts/Recalls
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