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Burst Balloons Prompt Edwards to Add Warning to Sapien 3 Ultra Delivery Instructions

The FDA safety notice comes less than a week after FDA expanded indications of transcatheter aortic valves made by both Edwards Lifesciences and Medtronic, making the devices available for use in younger and lower-risk patients.

The recall marks the 37th medical device recall FDA has reported in 2019. That's quite a bit considering that in 2018 and 2017 FDA reported only a total of 32 device recalls each year. These numbers are based on the agency's list of 2019 medical device recalls and do not include recalls that have been initiated and/or reported but not yet added to FDA's website.

Data Source: FDA; Graph by Amanda Pedersen

Reports of balloons bursting during transcatheter aortic valve replacement (TAVR) implantation procedures prompted Edwards Lifesciences to issue a field safety notice in July with instructions for physicians who treat patients with the Sapien 3 Ultra valve.

FDA issued this safety alert on Aug. 22 calling the action a recall. However, an Edwards spokesperson told MD+DI that the device is not actually being pulled from the market and no devices are being returned as part of this action.

The reported incidents of burst balloons during implantation procedures have resulted in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, which may cause vascular injury, bleeding, or the need for surgical intervention. The issue has resulted in 17 injuries and one death, FDA noted.

The news of this action comes less than a week after FDA expanded indications of transcatheter aortic valves made by both Edwards Lifesciences and Medtronic, making the devices available for use in younger and lower-risk patients.

In addition to giving physicians specific instructions regarding the risk of balloon rupture and what to do if a balloon burst is suspected, the company will add the following warning to the Sapien 3 Ultra's 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.

FDA has reported a total of 37 medical device recalls so far this year compared to 17 device recalls this time last year, and a total of only 32 device recalls the entire year, according to FDA's database. The agency also reported 32 device recalls in 2017, and 39 device recalls in 2016.

See the chart above for a complete month-by-month breakdown of recalls in the medical device sector from 2016 through 2019 (as of Aug. 22, 2019). This is Edwards' fifth recall so far this year.

Other companies that have recalled medical devices this year include (in order from most recent): Medline Industries, Fresenius Kabi, Abbott, Becton Dickinson, Teleflex, GE Healthcare, Hamilton Medical, Vyaire Medical, Cook Medical, Terumo Medical, Integra Lifesciences, Beckman Coulter Lifesciences, Ethicon (Johnson & Johnson), Alpha Omega Engineering, Brainlab, O-Two Medical Technologies, RVO 2.0, Physio-Control, Medtronic, Smiths Medical, West Pharmaceutical Services, Terrific Care/Medex Supply, Draeger Medical.

For details about 2019 medical device recalls, click here. For 2018 recalls, click here. For 2017 recalls, click here.

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