Boston Scientific Heart Devices Tied to Injuries and Deaths: FDA Issues Warnings

The FDA has flagged two Boston Scientific heart devices, a defibrillator system and a heart implant, due to safety issues. The defibrillator wires can become calcified, leading to failures in delivering life-saving shocks, and the heart implant has an increased risk of blockages in the bloodstream. Boston Scientific has reported 386 serious injuries and 16 deaths related to the defibrillator issue, and 120 serious injuries and 17 deaths related to the heart implant issue. The company's shares fell nearly 1.8% on Wednesday.

The U.S. Food and Drug Administration (FDA) has flagged two Boston Scientific (NYSE:BSX) heart devices due to safety issues, leading to a nearly 1.8% drop in the company's shares on Wednesday. The issues involve the company's defibrillator system and a heart implant, both of which have been linked to serious injuries and deaths.

Defibrillator System Issues

Boston Scientific has reported 386 serious injuries and 16 deaths related to its defibrillator system, specifically the ENDOTAK RELIANCE leads with expanded polytetrafluoroethylene (ePTFE) coated coils. The FDA has become aware of a potentially high-risk issue with these leads, which may impact shock efficacy and require early replacement. The most common harm is early lead replacement, while the most serious harm is death or the need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from reduced shock energy due to high impedance [2].

The issue is linked to a trend of gradually rising low-voltage shock impedance (LVSI) correlated with shock coil calcification, which is more prevalent with Boston Scientific's RELIANCE ePTFE defibrillation leads compared to non-ePTFE leads. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available [2].

Heart Implant Issues

The FDA has also flagged an issue with Boston Scientific's WATCHMAN Access Systems, which have been linked to an increased risk of blockages in the bloodstream. The company has reported 120 serious injuries and 17 deaths related to this issue. The FDA has become aware of a potentially high-risk device issue with these systems, which may increase the risk of air embolism during procedures performed without positive pressure-controlled ventilation [1].

Boston Scientific has recommended reviewing updated instructions for use (IFU) related to air embolism and ensuring notification of this medical device advisory to any clinicians who perform WATCHMAN procedures. The company has also reported that patients under deep or conscious sedation are at increased risk for negative left atrial pressures, especially in the presence of hypovolemia or partial upper airway obstruction [1].

Impact on Share Price

The safety issues with Boston Scientific's heart devices have led to a nearly 1.8% drop in the company's shares on Wednesday. The stock fell from $302.55 to $297.93, according to data from Investing.com [2].

Conclusion

The FDA's alerts on Boston Scientific's heart devices highlight the importance of ongoing safety monitoring and the potential risks associated with medical devices. Investors should closely monitor the situation and the company's response to these issues.

References

[1] https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-watchman-access-system-issue-boston-scientific
[2] https://www.investing.com/news/stock-market-news/boston-scientific-stock-falls-after-fda-discloses-defibrillation-lead-issue-93CH-4173852