All available information was investigated and the reported difficult to remove was not confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.The investigation determined the reported difficult to remove the device appears to be related to procedural condition.A cause for the reported thrombosis cannot be determined.Thrombosis is listed in the mitraclip instructions for use as a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstance.There is no indication of a product issue with respect to manufacture, design, or labeling.
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