Catalog Number CDS0501 |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problems
Death (1802); Tissue Damage (2104)
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Event Date 01/18/2018 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.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 is filed to report a chordal rupture and the patient death.It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr) with a flail.Leaflet grasping attempts failed, due to the prolapsed leaflet and a chordae rupture was observed.The procedure was aborted, without clip implantation.Surgical intervention was recommended, but the patient declined and wished to die peacefully.On (b)(6) 2018, the patient died from cardiogenic shock secondary to severe mitral regurgitation.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the reported failure to adhere or bond to the leaflets appears to be related to patient morphology/pathology (prolapsed leaflet).The reported death was due to the cardiogenic shock and the shock was secondary to the severe mitral regurgitation (mr).The reported tissue damage appears to be related to procedural circumstances of the failure to adhere or bond to the leaflets.The reported patient effects of death, mitral valve injury (tissue damage), and cardiogenic shock, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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