SOLITAIRE FR

Description of Event or Problem

Tian D, Yu H, Liu Q. Fatal Thrombosis of the Internal Carotid Artery Following Surpass Evolve Flow Diverter Treatment of an Intracranial Aneurysm. Journal of Craniofacial Surgery. 2025;36(7):e1065-e1068. doi:10.1097/SCS.0000000000011720. Literature was reviewed regarding ¿Fatal Thrombosis of the Internal Carotid Artery Following Surpass Evolve Flow Diverter Treatment of an Intracranial Aneurysm.¿ The study was a single-patient case report of fatal internal carotid artery thrombosis following technically successful deployment of the surpass evolve flow diverter (SEFD) in a small, unruptured saccular aneurysm at the C6 segment of the right internal carotid artery (ICA). The following Medtronic devices were used: Rebar-18 microcatheter and Solitaire FR 4 × 20 mm stent retriever. On postoperative day 1, the patient was neurologically intact. Non contrast cranial CT was unremarkable. However, on postoperative day 2, they developed acute neurological deterioration. The patient developed sudden-onset vomiting, lethargy, and complete left-sided hemiplegia (muscle strength 0/5). Emergent cerebral angiography revealed complete thrombotic occlusion of the right ICA at the C1 segment. Thrombectomy was performed using an 8F guiding catheter positioned in the right common carotid artery. A combined technique was used, involving aspiration through a Rebar-18 microcatheter and thrombus retrieval using a Solitaire FR 4×20 mm stent retriever, to remove thrombus from the right middle cerebral artery (MCA) and residual clot from the ICA. Final angiography confirmed complete recanalization of the right ICA, MCA, and anterior cerebral artery (ACA). Postoperatively, intravenous tirofiban was resumed at 0.3 mg/h. Despite successful angiographic reperfusion, the patient¿s neurological condition deteriorated. Nine hours later, they became comatose. Cranial CT revealed a large right hemispheric infarction, compression of the right lateral ventricle, and significant midline shift. On the basis of the clinical and radiologic progression, re-occlusion of the ICA was suspected. An emergent decompressive craniectomy was performed for malignant cerebral edema and extensive right hemispheric infarction. A 12×14 cm bone flap was removed. Despite surgical intervention, the patient¿s condition continued to worsen. On postoperative day 1, they developed right pupillary dilation consistent with worsening intracranial hypertension. Despite aggressive medical therapy¿including osmotherapy, corticosteroids, and intravenous piperacillin/tazobactam¿their neurological status further declined.By postoperative day 2, they exhibited bilateral fixed pupils and loss of spontaneous respiration. Despite maximal medical and surgical efforts, including ventilatory and hemodynamic support, the patient ultimately succumbed to brainstem failure and refractory cardiorespiratory collapse. Retrospective review revealed that the patient had discontinued clopidogrel during a temporary discharge before the procedure and was not disclosed to the medical team. This unrecognized lapse in dual antiplatelet therapy likely contributed to the early thrombotic occlusion of the ICA.

Additional Manufacturer Narrative

Tian D, Yu H, Liu Q. Fatal Thrombosis of the Internal Carotid Artery Following Surpass Evolve Flow Diverter Treatment of an Intracranial Aneurysm. Journal of Craniofacial Surgery. 2025;36(7):e1065-e1068. doi:10.1097/SCS.0000000000011720. Earliest date of publication used for Date of Event. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported. Without return of the product no definitive conclusion can be made regarding the clinical observations. Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known.