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 seventeen months after device implant using a full root technique, a pseudoaneurysm of this aortic root bioprosthesis was observed via computed tomography.(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.) two holes 20 mm in diameter were noted in the device¿s left and noncoronary sinuses.Histologic examination showed that the holes were located in the shift from the aortic elastic wall to the collagen fibers.The device was replaced with a device of the same model and size.It was reported there were no subsequent adverse patient effects until the patient¿s second device required replacement.A separate report has been filed on that complaint.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.
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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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