It was reported that on (b)(6), 2023, a 24mm amplatzer post-infarct muscular vsd occluder was implanted using a 10f amplatzer trevisio intravascular delivery system.On (b)(6), 2023, the device embolized into the right ventricle.On and unknown date, the device was snared and moved into the left ventricle.It was noted that there was a large amount of resistance moving the device with the snare.Upon inspection of the device, it was noted that the device had deformed into a cobra shape.It is thought that the device was caught in the tricuspid cords, so when the occluder was deployed the right disk didn't form correctly or elongate.The patient is reported to be stable.No additional information was provided.
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An event of cobra shaped device deformity was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the amplatzer post-infarct muscular vsd occluder instructions for use instructions for use, arten600196897 revision a "warnings: caution: embolized devices must be removed.Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath.".
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