The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the cause of the reported perforation was unable to be determined.The reported off-label use was associated with the use of the mitraclip device on the tricuspid valve.The reported patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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It was reported that a mitraclip procedure was performed to concurrently treat degenerative mitral regurgitation (mr) grade 4 and degenerative tricuspid regurgitation (tr) grade 4.A ntw mitraclip was placed on the mitral valve successfully, reducing mr to grade 2.Once the sgc was moved to the right atrium, a right to left shunt was noted.An atrial septal defect (asd) occluder was then placed to treat the shunt.After the asd was placed, an attempt was made to place a mitraclip on the tricuspid valve utilizing the same steerable guide catheter (sgc).Due to unfavorable anatomy creating a difficult approach angle, the clip ended up becoming caught in the chordae.During removal there was chordal tearing.The clip was removed from the patient.Tr rose from severe to torrential.The procedure was aborted.No additional information provided.
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