Swissmedic granted exemptions for untested Cardioband heart implant despite fatal complications
Swissmedic approved the use of the experimental Cardioband implant at the University Hospital Zurich without demanding extra safety data, even after a wire break and a patient death.
Investigations show Swissmedic allowed the novel Cardioband heart-valve device to be used at the University Hospital Zurich without requiring additional safety assessments, despite the implant not being certified or previously tested on humans. A wire broke during the first procedure in 2016, and the hospital failed to file the incident through the official reporting system, instead sending a treatment report to Swissmedic.
The regulator accepted informal notifications and chose not to request further information, as internal correspondence indicates a desire to avoid being "too penetrant." Two more exception approvals followed, all resulting in leaky valves, and a third surgery caused coronary damage leading to a patient’s death. Swissmedic defended its actions, stating the applications were examined according to the legal framework at the time and that responsibility for off-label use rests with the treating physicians.
Why it matters
The case highlights gaps in medical device oversight that can endanger patients and erode trust in health regulators.
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