“Horn-shaped” deformity of the Occlutech®-PDA device: case report

INTRODUCTION: the deformation phenomenon of devices used for percutaneous closure in intracardiac defects has been reported, but not of devices for closure of patent ductus arteriosus. OBJECTIVE: to report a case of deformation of a relatively new type of device for closure of patent ductus arteriosus. METHOD: we report the case of an adult patient with hypertensive patent ductus arteriosus and a balloon occlusion test positive, whose occlusion was attempted with an Occlutech®-PDA device. RESULTS: when the device implantation was carried out it took the form of a "bicycle horn" instead of its usual form, which is a "champagne cork", reason why it was extracted prior to its release; some maneuvers were performed in order to verify its configuration and was inserted again, but when repositioning it suffered the deformation mentioned above so it was definitively removed. The procedure was performed with another device. CONCLUSIONS: to our knowledge, no deformations of the Occlutech-PDA device during its implantation have been published. Adverse events related to new technologies must be reported as it helps manufacturers to improve quality and provide greater safety to patients.