Livanova performed a review of the instruction for use (ifu) for the memo 4d semirigid annuloplasty ring.The results confirmed the presence of a dedicated section (i.E.Section 9.3.3.Use of the holder referred also in section 9.3.2, point d) which provides clear and detailed instructions to the safe and correct use of the device holder (defined as disk+template).Specifically, after detailing two possible configurations for the removal of the holder, this section includes a note of caution to further stress the importance of the holder removal: 'both parts of the holder must be removed from the device after implant and discarded.The implantation of the holder or its presence in the implant site may result in serious injury to the patient, or death.' based on the review performed, no deficiency has been identified in the instructions provided.The root cause of the reported event can be reasonably attributed to an off-label use of the device.Should additional information become available on this event, a follow up report will be submitted.Disposition unknown, unable to follow up.
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The manufacturer was informed that a patient received a memo 4d (implant date unknown).The blue template (holder) was reportedly not removed during the surgery, thus remaining implanted in the patient.The patient received reoperation in another center where the template was removed.It is reported that the patient required another surgery (not related to the memo 4d), and on this occasion, it was identified that the template was implanted in the patient.No symptoms were previously noted.
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