Maisano case: Swissmedic also under fire for lax oversight

The case of cardiac surgeon Francesco Maisano, at the centre of a medical scandal at Zurich University Hospital (USZ), now also involves Swissmedic, Switzerland's regulator for medicines and medical devices. An investigation by Swiss German-language broadcaster SRF, based on documents obtained under the freedom-of-information law, shows how the institute granted three exceptional authorisations for the use of the Cardioband without ever genuinely checking its safety.

The Cardioband is a ring fixed with metal anchors, designed to correct heart valve insufficiencies. In 2016 Maisano implanted it for the first time to treat a right-side valve. The device had no CE certification and had never been tested on humans for this type of procedure, so the hospital had to request an exceptional authorisation from Swissmedic. During the operation one of the wires broke, making a second implant necessary. The patient's valve continued to leak regardless.

Cardiac surgeon André Plass, who brought the scandal to light and later lost his job over it, describes the operation as "una catastrofe" (a catastrophe) and argues that, because of fundamental technical flaws, the Cardioband "non avrebbe mai dovuto essere impiantato nell'uomo" (should never have been implanted in a human being). The fixing screws, he explains, barely anchored in a beating heart.

According to the documents reviewed by SRF, Swissmedic granted the 2016 authorisation without asking either the manufacturer or the hospital any questions about safety. Jörg Goldhahn, a professor at ETH Zurich, speaks of "una rinuncia alla verifica" (a waiver of scrutiny) incompatible with Swissmedic's mandate. Swissmedic responds that it acted according to criteria that were "basati sul rischio e proporzionati" (risk-based and proportionate), adding that final responsibility for using an uncertified product rests with the doctor.

Two further authorisations with no clarification

The hospital reported the wire breakage not through the formal channel required, but within a clinical report, while the manufacturer did not report it at all. Internal emails show that Swissmedic knowingly chose not to press for further documents. In the following ten weeks the institute nonetheless granted a second exceptional authorisation, in September 2016, and a third in January 2017, without requesting any new safety clarifications.

None of the three patients treated with the Cardioband saw their valve insufficiency resolved. During the third procedure a coronary artery was injured, and the patient died eighteen days later. Swissmedic maintains that the documentation, supplied by the hospital, showed no direct link between the death and the device, but acknowledges it carried out no independent inquiry of its own.

A USZ inquiry commission concluded in May that the Cardioband had brought no lasting clinical improvement, while carrying significant risks. The manufacturer withdrew the device from the market in 2024 and declined to comment.

Swissmedic rejects the criticism and states that it exercised its oversight function "in ogni momento e conformemente al mandato ricevuto" (at all times and in line with the mandate received). Goldhahn counters that "limitarsi a raccogliere documenti significa fare archivio, non vigilanza" (merely collecting documents means keeping an archive, not exercising oversight). Since 2021 the Federal Council has also abolished the authorisation requirement for uncertified medical devices, leaving doctors with full responsibility in individual cases. For Goldhahn this is "un passo indietro per la sicurezza dei pazienti" (a step backward for patient safety), since no register exists today to track the use of the highest-risk devices.