HAART Aortic Annuloplasty Device

Description of Event or Problem

The manufacturer was informed of an aortic valve repair involving a HAART Annuloplasty Ring. The following provides a summary of all the information currently available from the healthcare facility. A HAART Annuloplasty Ring was implanted in a patient that required reoperation because it was later realized that the annulus had been reduced too much. The surgeon emphasized the need for a larger size for the bicuspid ring. No further information is available at this time.

Additional Manufacturer Narrative

As the device lot number was not provided, a review of the manufacturing records could not be performed. Based on the available information, the reported event can reasonably be attributed to an initial incorrect assessment of the appropriate ring size for the patient's annulus. According to the surgeon, the event occurred a long time ago, making it difficult to obtain additional details regarding the case. Should any new information become available, a follow-up report will be submitted.