The agency alert says FDA has learned of death, stroke, detachment, and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage, and abdominal bleeding associated with the experimental procedure. Balloon angioplasty devices and stents are not approved by FDA for treating cerebrospinal venous insufficiency, it says.
FDA says it also is reminding doctors or clinical investigators planning or conducting clinical trials using medical devices to treat cerebrospinal venous insufficiency that they must comply with agency regulations for investigational devices. A February Warning Letter was sent to a sponsor/investigator who was conducting a clinical study of such treatment without the necessary approval, the alert says. The sponsor/investigator reportedly voluntarily closed the study.