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Patient Death Prompts FDA Recall of Faulty Edwards Heart Valve Part

The Food and Drug Administration (FDA) has issued a Class 1 recall for a faulty component of the Edwards SAPIEN 3 transcatheter heart valve system, following reports of 17 injuries and one death.

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By Fred Donovan

- The Food and Drug Administration (FDA) has issued a Class 1 recall (most serious) for a faulty component of the Edwards SAPIEN 3 transcatheter heart valve system, following reports of 17 injuries and one death.

Edwards Lifesciences received reports that the delivery component of the heart valve system experienced burst balloons during implantation, which resulted in difficulty retrieving the valve into the catheter and withdrawing the system from the patient. These problems could result in injury, bleeding, or the need for surgery.

Those affected by the recall include U.S. patients who had a transcatheter aortic valve replacement procedure using the Edwards SAPIEN 3 transcatheter heart valve system starting January 3, 2019, as well as the physicians who used the systems.

Edwards Lifesciences sent July 9 an urgent field safety notice with recommendations and instructions for physicians.

In addition, the following warning is being added to the Edwards SAPIEN 3 transcatheter heart valve system instructions for use: "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."

Edwards said that if physicians suspect balloon bursts, they should not attempt to pull back the delivery system into the sheath until they are prepared to take the following actions:

  • Close stopcock to the delivery system and remove inflation device from stopcock.
  • Continuously twist the handle in a clockwise direction (full 360-degree rotations) while pulling back the delivery system into the sheath tip. Verify delivery system tip has entered the sheath tip under fluoroscopy.
  • 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 using other interventional techniques for retrieval.
  • 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.
  • 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 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.

Health Canada also issued a recall for the Edwards SAPIEN 3 transcatheter heart valve system delivery component. The model numbers affected by the recall are 9630TF20, 9630TF23, 9630TF26, 9630TF29.