The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other complaints reported from this lot.The reported patient effect of venous perforation, as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.Based on the information provided the reported failure to advance is the result of patient anatomy.A conclusive cause for the reported venous perforation cannot be determined.The reported additional therapy / non-surgical procedure is the result of case specific circumstances as a stent was used to treat the venous perforation.There is no indication of a product issue with respect to manufacture, design, or labeling.
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