The user facility reported a 79-year-old female noted as high risk percutaneous coronary insertion was implanted with an impella cp device for mechanical circulatory support.It was reported that during implantation, the impella cannula developed a kink upon insertion, however the valve was crossed with minimal resistance allowing approximately 2.3 liters of flow, and all three vessels had orbital atherectomy followed by stenting.
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The impella device was not received from the customer and therefore, an evaluation of the device was not possible.Upon investigation closure, a supplemental mdr will be filed.Instructions for use for the related event are as follows: ¿avoid manual compression of the inlet and outlet areas of the cannula assembly.¿ ¿handle with care.The impella catheter can be damaged during removal from packaging, preparation, insertion, and removal.Do not bend, pull, or place excess pressure on the catheter or mechanical components at any time.¿ this report is being filed as part of a retrospective review of historical records.
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