Catalog Number CDS0502 |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problems
Mitral Valve Stenosis (1965); Tissue Damage (2104)
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Event Date 02/28/2018 |
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 customer reported the clip delivery system 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 the tissue damage and mitral stenosis.It was reported that the patient, with grade 4 mixed mitral regurgitation (mr) and a mean pressure gradient of 2mmhg, underwent a mitraclip procedure.Two clips were successfully implanted one at the anterior 2/posterior 2 (a2/p2) leaflet segment and the other at the anterior 3/posterior 3 (a3/p3) leaflet segment.The mean pressure gradient increased to 3 mmhg, but mr was reduced to grade 2-3.It was decided to implant a third clip between the two previously implanted clips.Some difficulty was noted grasping the leaflets and a new jet was noted between the two implanted clips.It was felt that the new jet was due to a leaflet perforation.The clip was not implanted and the clip delivery system was removed without issue.An amplatzer plug was placed to seal the leaflet perforation.The procedure ended with mr at grade 1.The mean pressure gradient increased to 7 mmhg.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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effects of mitral stenosis and mitral valve injury (tissue damage) as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.All available information was investigated and a definitive cause for the reported failure to adhere or bond could not be determined.The reported mitral valve injury (tissue damage) appears to be related to the reported failure to adhere or bond and patient effect of mitral stenosis was due to procedural circumstances as the mean gradient pressure remained 7mmhg at the end of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.
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Search Alerts/Recalls
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