Medical device manufacturer, Medtronic Inc has issued a medical device safety alert concerning CoreValve AccuTrak Delivery Catheter System (DCS). Models DCS-C4-18Fr and DCS-C4-18Fr-23 are affected.
As of 31 October 2013, Medtronic has received 38 reported nose cone separation events (0.08 percent of implant procedures). 5 of these reported events (0.01 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 labeling. 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.
To reduce the occurrence of nose cone separations, Medtronic is modifying the instructions for use and training materials for CoreValve AccuTrak DCS models DCS-C4-18Fr and DCS-C4-18Fr-23. Meanwhile, users are advised to consider the following recommendations during the CoreValve implant procedure:
- While the DCS is in the patient, ensure the guidewire is extending from the nose cone, and do not remove the guidewire from the catheter while the catheter is inserted in the patient.
- Once deployment is initiated, retrieval (removal) of the bioprosthesis from the patient is not recommended. Partial repositioning, if needed, should be followed per the IFU guidance.
- Before DCS removal, ensure the capsule is closed. If the capsule does not close properly, gently rotate the catheter clockwise (<180°) and then counterclockwise (<180°) until the capsule closes.
- If there is increased resistance when removing the DCS through the introducer sheath, do not force passage as increased resistance may indicate a problem and may result in damage to the device and/or harm to the patient. If the cause of resistance cannot be determined or corrected, remove the catheter and introducer sheath as a single unit over the guidewire, and inspect the catheter.
According to the local supplier, the affected products were distributed to Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 November 2013