FDA WARNING_LETTER - Vivek K. Reddy, MD - December 08, 2015

This FDA Warning Letter, dated March 4, 2015, addresses Dr. Vivek K. Reddy regarding objectionable conditions observed during an FDA inspection of his clinical site from November 9 to December 8, 2015. The inspection assessed compliance with federal regulations for the "Solitaire FR With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke" study (IDE G120142, De Novo DEN150024).

The letter cites serious violations of 21 CFR Part 812 - Investigational Device Exemptions. Key violations include:

1. **Failure to conduct the investigation in accordance with the investigational plan [21 CFR 812.100]:** * Non-standard catheter dilatation using a Neuron Max sheath for cervical internal carotid artery recanalization on Subjects 103002 and 103008, placing them at high risk. * Failure to complete the 90-day assessment for Subject 103007 by a blinded independent evaluator. * NIH Stroke Scales for Subjects 103042 and 103038 not performed by certified study personnel. * Serious adverse events (Intracranial Hemorrhage, Mural Thrombus and Hemorrhagic Infarct, Hemorrhagic Transformation, Hemorrhagic