Catalog Number CDS02ST |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
Mitral Regurgitation (1964)
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Event Date 05/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Event Description
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This report is filed since the implanted mitraclip partially detached from one leaflet.It was reported that on (b)(6) 2016, a mitraclip (cds0502 51030u159) was implanted without reported issue reducing the mitral regurgitation (mr) from grade 4 to 1.On (b)(6) 2018, during a follow-up visit, the mitraclip was noted partially detached from the anterior leaflet, while remaining attached to the posterior leaflet.On (b)(6) 2018, another procedure was performed for degenerative mitral regurgitation, grade 3-4.One mitraclip was implanted without reported issue, reducing the mr to grade no additional information was provided regarding this issue.
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Manufacturer Narrative
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Internal file number: (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Correction: catalog number.Correction: on the initial, 30 day medwatch report, the date was incorrect.The correct date should have been (b)(6) 2018.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The reported patient effect of worsening mitral regurgitation (mr), as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.All available information was investigated and the reported difficulty grasping appears to be related to patient morphology/pathology (pre-existing flail).The reported worsening mr was a result of patient/procedural conditions and due to the possible clip movement on the leaflets.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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Subsequent to the initial medwatch report, the additional information was received:
the patient presented at the index procedure with leaflet flail.Reportedly, the partial leaflet detachment was most likely due to pre-existing anatomy and leaflet flail, although this could not be certain.There was no evidence of tissue damage.
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Search Alerts/Recalls
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