| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00015-1 |
| Product Name/Description |
Mosaic Porcine Aortic Bioprosthesis Model 305 and Medtronic Aortic Obturators/Sizers and iOEA Charts
Hazard Alert - MosaicPorcine Aortic Bioprosthesis Model 305
All sizes and configurations ie, Standard and Ultra
ARTG 145761
Recall - Medtronic Aortic Obturators/Sizers and iOEA -indexed Effective Orifice Area Charts
Model Numbers: 7305, 7305OD, 7305UX
ARTG 98977 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
The current Mosaic Aortic Bioprosthesis sizing chart and Obturators/Sizers may contribute in some cases to the selection of a larger than optimal Mosaic Aortic Bioprosthesis. Medtronic has determined that the practice of substantial oversizing can lead to the reported cases of higher-than-expected transvalvular gradients post implantation. Specifically, considerable oversizing, or implanting a valve substantially larger than the native aortic annulus, may result in the alteration of normal leaflet movement as blood flowing through the native annulus may not properly match the size and/or shape of the inflow of the Mosaic Aortic Bioprosthesis. The higher-than-expected transvalvular gradients (> 25 mmHg) have occurred at a rate of 0.33 percent (3.3 reports per 1000 aortic implants). A subset of these valves were explanted within five years of implantation at an overall occurrence rate of 0.1 percent (1 explant per 1000 aortic implants). |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Medtronic is not making any specific patient management recommendations for the patients implanted with the Medtronic Mosaic Aortic Bioprosthesis. Surgeons and cardiologists should continue to follow their patients per their usual practice and in accordance with published guidelines. Medtronic has updated the iEOA Mosaic Aortic Bioprosthesis sizing chart and also, modified the current Mosaic Obturators/Sizers to align with the updated sizing chart. The IFU for the modified Mosaic Obturators/Sizers has been updated to include the new sizing chart (iEOA chart). Medtronic recommends surgeons continue to remain diligent in selecting the appropriate size of Mosaic Aortic Bioprosthesis. Adoption of the updated Mosaic Aortic Bioprosthesis sizing chart (iEOA chart) and Mosaic Obturators/Sizers will facilitate optimal aortic valve size selection. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-bioprosthesis-140128.htm . |
| Contact Information |
1800 668 670 - Medtronic Customer Service |