Burst Balloons With Sapien 3 Ultra Prompt ‘Urgent Field Safety Notice’ and Canadian Recall

Edwards is alerting operators about reports of burst balloons that have led to complications in retrieving the delivery system.

Burst Balloons With Sapien 3 Ultra Prompt ‘Urgent Field Safety Notice’ and Canadian Recall

Edwards Lifesciences has issued an urgent field safety notice for its Sapien 3 Ultra transcatheter heart valve system after reports of burst balloons.

The burst balloons “have resulted in significant difficulty retrieving the SAPIEN 3 Ultra delivery system into the sheath and withdrawing the system from the patient,” the notice reads.

Last week, Health Canada identified the field safety notice as a Type I medical device recall, which the agency defines as “a situation in which there is a reasonable probability that the use of (or exposure to) a recalled device will cause serious adverse health consequences or death,” an agency representative told TCTMD. In Canada, a recall can entail removal of a medical device or a halt to use, but can also include lesser actions, including advising users of a problem or supplying different labeling.  

According to an Edwards spokesperson, the Ultra is available at “some” hospitals in the United States, after being cleared by the FDA in late 2018. Based on “limited experience with the device,” the observed complaint rate for burst balloons is approximately 1%, the company said in their letter to providers, and an estimated 0.5% of burst balloons entailed clinical implications for the patient, such as difficulties with delivery system removal, vascular injury, bleeding, and/or need for surgical intervention.

Valve deployment was successful in these cases,” the field safety notice reports. “Following investigations into these events, Edwards has not identified any evidence of devices that did not conform to specifications.”

Models affected in the recent field action include all lot numbers of models 9630TF20, 9630TF23, 9630TF26, 9630TF29.

Shelley Wood is Managing Editor of TCTMD and the Editorial Director at CRF. She did her undergraduate degree at McGill…

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