Medtronic received information from a journal article that a patient implanted with an aortic root bioprosthesis experienced a post-implant spontaneous perforation of the device¿s valsalva sinus.It was reported that the patient presented to a hospital with cardiopulmonary arrest and subsequently expired 51 months after undergoing a full root technique.(in the full root technique, the valve was implanted with the whole system and the coronary buttons were anastomosed to the right and left coronary ostium correspondingly.) the autopsy showed there was a large pseudoaneurysm with a hole in the non-coronary sinus that resulted in aortic rupture of the pseudoaneurysm to the right thorax.Pathologic findings showed that the defect in the noncoronary valsalva sinus was at the transitional border between the elastic tissue and collagen fibers.There was no evidence of infection or suture line dehiscence.The article noted that these patients were part of a population who had their devices implanted between october 1999 and december 2002; the date of this complaint was not indicated in the article.The date of death entered for this report is an arbitrarily chosen date to facilitate electronic submission of the report, as the date of death is unknown at this time.
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A review of the maude database entries for this model family did not show a report had previously been submitted for this journal article or individual complaint.A review of medtronic¿s databases did not find a previously existing record for this article or individual complaint.(b)(4).Perforation of the valsalva sinus after implantation of medtronic freestyle aortic bioprosthesis nobuchika ozaki, md; yutaka hino, md; yuji hanafusa, md; teruo yamashita, md; kenji okada, md; takuro tsukube, md; and yutaka okita, md kobe university graduate school of medicine, division of cardiovascular, thoracic, and pediatric surgery, kobe, japan the annals of thoracic surgery, volume 82, issue 6, december 2006, pages 2282¿2285 doi:10.1016/j.Athoracsur.2006.04.074.
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