Important Safety Alerts

The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning JenaValve prosthesis, manufactured by JenaValve Technology.

The manufacturer has received notice that during a routine implantation in an AR patient using a size 27 JenaValve prosthesis, significant paravalvular leakage (PVL) occurred despite adequate positioning and deployment of the prosthesis. As PVL did not resolve following repeat balloon valvuloplasty, a valve-in-valve procedure had to be performed.

Prior to the procedure, a standardized MDCT scan and software-mediated three dimensional reconstructions were used to calculate the patient's native annular size and choose the corresponding prosthesis. Annular dimensions in diastolic phase of the cardiac cycle were used. During the manufacturer's investigation, repeat assessment of the MDCT data in both diastolic and systolic phase was performed. It has become apparent that during systolic assessment, the patient's annular size was significantly larger if compared to diastolic assessment and, in this specific case, potentially lead to prosthesis undersizing and PVL.

The manufacturer has recommended the following measures for this issue:-

• Always use systolic MDCT data (10-20% of the cardiac cycle) to assess the largest annular dimension prior to selecting the corresponding prosthesis size to avoid potential undersizing and associated paravalvular leakage.
• Perform systolic assessment of annular dimensions in both AS and AR patients, as also in calcified AS, systolic annular dimensions are larger in systole if compared to diastole, thus impacting prosthesis size selection.

For details, please refer to the MHRA website:
https://www.gov.uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-5-to-9-october-2015

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 13 October 2015