An event of residual shunt was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.An initial review of complaints data was reviewed on april 21 2020, as a component of the complaint handling risk review per (b)(4).The medical device problem and aho codes are consistent with the hazards/harms identified for this product family, and no new hazards or harms were identified.
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It was reported in an article titled, "complications and mid-term outcome after percutaneous patent foramen ovale closure in patients with cryptogenic stroke" that on an unknown date, a patient was implanted with an amplatzer pfo device.One year post procedure, the patient developed transient ischemic attack due to residual shunting.No additional information was provided.
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