As reported in a research article, an amplatzer pfo occluder was noted to have embolized six weeks after implant and the patient had an arrhythmia.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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The article, "a very rare and unusual complication after a percutaneous patent foramen ovale closure" was reviewed.The article presented a case study of a 47-year-old female who presented with an atrial septal aneurysm and patent foramen ovale (pfo).It was reported that on an unknown date, a 25mm amplatzer pfo occluder was implanted to occlude a pfo without issue and reassuring tug test.Six weeks post procedure, the patient presented with palpitations and subsequent imaging revealed the device had embolized into the descending aorta.A decision was made to explant the device via transcatheter snare.The article concluded that this case demonstrated that percutaneous retrieval of an embolized pfo occluder, although challenging, is feasible and might be a viable alternative to a riskier conventional surgical approach, with the double snare technique and large sheath usage potentially improving success rates and reducing re-embolization risks.[the primary and corresponding author was claudiu ungureanu, cardiovascular jolimont hospital, rue ferrer, 159, 7100 la louvière, belgium; and 2cardiovascular department, clinique saint joseph, vivalia, arlon, belgium, with corresponding email: claudiu.Ungureanu@jolimont.Be].
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