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Eur J Cardiothorac Surg 2004;25:145
© 2004 Elsevier Science NL


Letter to the Editor

Anastomotic devices for coronary bypass: lethal complications have been previously reported!

Aristotle D. Protopapas*

Department of Cardiothoracic Surgery, St Mary's Hospital, Paddington, London, UK

Received 5 August 2003; accepted 20 October 2003.

* 26 Abbott's Ann Road, Winchester SO22 6NB, UK. Tel.: +44-7956897683; fax: +44-2085462901
e-mail: aristotelis.protopapas{at}ic.ac.uk

Key Words: Anastomosis • Anastomotic device • Complication • Coronary surgery • Coronary bypass • Quality control

I read with interest the referenced article [1]. The authors state a paucity of reported serious complications of the first generation ‘Symmetry Bypass System’ device (pp. 925–6).

I note that, according to the Manufacturer and User Facility Device Experience Database (MAUDE) of the Food and Drugs Administration (FDA) in the USA [http://www.fda.gov/cdrh/maude.html, see on-line search], there had been, up to the date of the final submission of this paper, 61 separate incident reports (some of which fatal).

Would the authors feel the need to modify their aforementioned statement?

Footnotes

The authors of the original paper [1] were invited to comment on this Letter to the Editor but declined the offer.

References

  1. Zehr K.J., Hamner C.H., Bonilla L.F., Berg T., Cornelius R., Hindrichs P., Schaff H.V. Evaluation of a novel 2 mm internal diameter stainless steel saphenous vein to coronary artery connector: laboratory studies of on-pump and off-pump revascularization. Eur J Cardiothorac Surg 2003;23:925-934.[Abstract/Free Full Text]



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