According to the latest data from the U.S. Food and Drug Administration (FDA), as of December 23, medical device giant Boston Scientific has reported 167 serious injury incidents related to specific stent products, and confirmed that three patient deaths are associated with device issues.
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This disclosure has once again raised concerns about the safety of cardiovascular implant devices. Regulatory documents show that the related cases involve stent structural abnormalities or post-implantation complications, with specific technical details still under further investigation. The company stated that it is cooperating with the FDA to conduct a comprehensive assessment and has initiated product traceability and clinical follow-up procedures.
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