As reported in a research article, a patient had an amplatzer septal occluder which dropped into the pleural cavity after the fistula it was implanted in progressed.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.Please note, per the instructions for use, artmt 100092311 revision b "the amplatzer septal occluder is a percutaneous, transcatheter atrial septal defect closure device intended for the occlusion of atrial septal defects (asds) in secundum position or patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration.".
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Related manufacturer reference number: 2135147-2020-00225, 2135147-2020-00226.It was reported through a research article identifying amplatzer atrial septal defect device that may be related to a device embolization.Details are listed in the article, titled "endoscopic closure of a bronchopleural fistula after pneumonectomy with the amplatzer occluder: a step forward?" it was reported in the article that a (b)(6) years old female with tuberculosis has a 8mm fistula.A 12mm ampaltzer septal defect occluder was implanted in march 2017.Severe exacerbation of tb occurred after violation of the treatment regimen.The fistula progressed and the occluder dropped into the pleural cavity.The patient died of tb 6 months after the occlusion.
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