It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.One clip was successfully implanted.To further reduce mr, an additional clip was inserted and grasping was performed.However, after the leaflets were grasped, the mean pressure gradient increased to 8mmhg.Due to the increased gradient, the physician decided to remove the clip.Upon removal, the clip was was caught on the tip of the steerable guide catheter (sgc).It was noted that the mandrel was bent.Troubleshooting was performed, but the clip got caught again.Therefore, the physician decided to removed both mitraclip devices simultaneously.The devices were able to pass through the septum, but was caught in the groin area.A vascular surgeon was able to surgically remove the mitraclip devices.There was no clinically significant delay in the procedure.
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated, and a cause for the bent mandrel and difficult to remove the cds from the sgc resulting in entrapment of device (clip becoming caught in anatomy) cannot be determined.Surgical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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