(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip remains in the patient 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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This is filed to report the increased mitral regurgitation (mr) with possible clip movement and tissue damage.It was reported that this was a mitraclip procedure on (b)(6) 2016 to treat degenerative mr with a grade of 4.Two clips ((b)(4)) were implanted reducing mr grade to 2.On (b)(6) 2018, the patient presented in the office symptomatic with increased dyspnea with daily activities.A transthoracic echocardiogram (tte) was performed and it was found that the mr had increased to 4.The patient refused a transesophageal echocardiogram (tee); therefore, it could not be determined if this was due to progression of disease or possible movement of clip / chordal damage.There was no treatment performed and no hospitalization.No additional information was provided.
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(b)(4).It could not be confirmed which implanted clip had the possible clip movement; therefore, the lot history record (lhr) and complaint history risk assessment was performed on both clips.The results are as follows: part / lot: cds0201/60203u101, date of manufacture: 03-feb-2016, expiration date: 28-feb-2017.Part / lot: cds0201/60401u202, date of manufacture: 04-apr-2016, expiration date: 30-apr-2017.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lots that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and a definitive cause for the partial clip movement in this incident could not be determined.Additionally, a definitive cause for the reported tissue damage, dyspnea and recurrent mitral regurgitation (mr) could not be determined.The reported patient effects of dyspnea, recurrent mr, and tissue damage as listed in the mitraclip system instructions for use, are known possible complication associated with mitraclip procedures.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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