| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01253-1 |
| Product Name/Description |
CoreValve AccuTrak Delivery Catheter System (DCS) (Intended to deliver CoreValve Transcatheter Aortic Valve, which is designed to treat severe aortic valve stenosis without open-heart surgery or surgical removal of the native valve)
Models DCS-C4-18Fr and DCS-C4-18Fr-23
Supplied in Australia under the Clinical Trial Notification (CTN) and Authorised Prescriber Schemes |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has received thirty-eight (38) reported nose cone separation events (.08 percent of implant procedures); five (5) of these reported events (.01 percent of implant procedures) led to the need for surgical intervention. A thorough review and investigation of the reported events has identified that a majority of these reported events occurred in situations cautioned against in current labelling. In addition, Medtronic has determined that the following situations can lead to nose cone separations:
-Using the CoreValve AccuTrak DCS to retrieve (remove) a partially deployed valve.
- Removing the CoreValve AccuTrak DCS from the patient, after valve deployment, without fully closing the CoreValve AccuTrak DCS capsule.
-Continuing to pull on the CoreValve AccuTrak DCS if increased resistance is felt at the vessel introducer, the introducer’s hemostatic valve, or other structure during CoreValve AccuTrak DCS retrieval. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To reduce the occurrence of nose cone separations, Medtronic is modifying the instructions for use (IFU) and training materials for CoreValve AccuTrak DCS models DCS-C4-18Fr and DCS-C4-18Fr-23. Medtronic is advising that physicians implement the updated IFU recommendations to reduce occurrences of nose cone separation events during the CoreValve implant procedure. |
| Contact Information |
1800 668 670 - Medtronic Australasia Customer Service |