Early Alert: Thoracic Stent Graft Issue from Bolton Medical
Bolton Medical thoracic stent grafts may fail to unclasp from the delivery system during deployment. This malfunction may necessitate an immediate conversion to open surgical repair and has been associated with patient death.
Bolton Medical, manufacturers and users of thoracic stent graft systems, and clinical teams performing endovascular repairs.
The potential for mortality and the requirement for emergency open surgery suggest a high-risk failure mode involving the delivery system's mechanical interface. This represents a significant safety signal that likely necessitates immediate field action, thorough root cause analysis of the deployment mechanism, and potential revisions to the device's Instructions for Use (IFU) or design.
Quality and clinical teams should immediately identify affected inventory and review surgical protocols for emergency conversion to open repair. Regulatory departments must prepare for potential high-priority reporting requirements or further enforcement actions based on this safety signal.
Affected grafts may not unclasp from the delivery system, which may require conversion to open surgical repair and can result in patient death
Open in openFDA / FDA.gov