Edwards Recalls Part of Transcatheter Heart System After One Death

Regulatory NewsRegulatory News | 22 August 2019 |  By 

Last month, Edwards Lifesciences recalled its SAPIEN 3 Ultra Delivery System after reports of burst balloons during implantation, resulting in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, the US Food and Drug Administration (FDA) said Thursday.

FDA said 17 injuries and one death were reported at the time when Edwards initiated the Field Corrective Action early last month. “The use of affected product may cause serious adverse health consequences, including death,” FDA said in announcing the Class 1 recall.

The device is used to deliver and deploy the Edwards SAPIEN 3 Ultra transcatheter heart valve or the Edwards SAPIEN 3 transcatheter heart valve to replace a diseased aortic valve without open-heart surgery.

In its Urgent Field Safety Notice to customers on 9 July, Edwards offered the following three recommendations for physicians:
  1. “When deploying the valve, inflate the balloon slowly and continuously throughout deployment. Hold for 3 seconds at full inflation. The delivery system requires a prescribed volume for THV deployment and proper function (11 mL, 17 mL, 23 mL, 33 mL).
  2. The following warning will also be added to the Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System Instructions for Use (IFU): 'Failure to use slow, controlled inflation and prescribed nominal inflation volumes may result in balloon rupture, difficulty retrieving the delivery system, and may require subsequent conversion to surgical intervention.'
  3. If a balloon burst is suspected, do not attempt to pull back the delivery system into the sheath until you are prepared to conduct the following technique:
    1. Close stopcock to the delivery system and remove inflation device from stopcock.
    2. Continuously twist the handle in a clockwise direction (full 360o rotations) while gently pulling back the delivery system into the sheath tip. Verify delivery system tip has entered the sheath tip under fluoroscopy.
    3. DO NOT FORCE if resistance is met near or at the sheath tip. Forcing retrieval when meeting resistance could result in additional balloon material tearing or tip dislodgement. Consider utilizing other interventional techniques for retrieval (e.g., a snare).
    4. If successful in pulling the entire balloon into the tip of the sheath, withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position. DO NOT attempt to pull the delivery system through the remaining length of the sheath.
    5. If resistance is still encountered, convert to surgery for device removal. Based on medical assessment of the size, tortuosity, and extent of calcification of the peripheral vessels, evaluate the risks and tradeoffs of carefully withdrawing the system into a more peripheral anatomy in order to allow a more localized procedure. Consider use of an occlusion balloon to mitigate bleeding risks.”


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