SOLITAIRE

Additional Manufacturer Narrative

THE SOLITAIRE STENTS HAVE NOT BEEN RETURNED FOR EVALUATION; PRODUCT ANALYSIS CANNOT BE PERFORMED. BASED ON THE PROVIDED INFORMATION, THERE DOES NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICES DURING USE. THE EVENTS OCCURRED IN THE PATIENTS POST-PROCEDURE AND THE CAUSES COULD NOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. MDRS RELATED TO THIS ARTICLE: 2029214-2018-00731 2029214-2018-00732. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

FAHED, R., MARIA, F. D., ROSSO, C., SOUROUR, N., DEGOS, V., DELTOUR, S., . . . CLARENÇON, F. (2017). A LEAP FORWARD IN THE ENDOVASCULAR MANAGEMENT OF ACUTE BASILAR ARTERY OCCLUSION SINCE THE APPEARANCE OF STENT RETRIEVERS: A SINGLE-CENTER COMPARATIVE STUDY. JOURNAL OF NEUROSURGERY, 126(5), 1578-1584. DOI:10.3171/2016.2.JNS151983 MEDTRONIC RECEIVED REPORT OF POOR OUTCOME OR DEATH AFTER SOLITAIRE THROMBECTOMY. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE SAFETY AND EFFECTIVENESS OF ENDOVASCULAR TREATMENT OF ACUTE BASILAR ARTERY OCCLUSION. THE AUTHORS RETROSPECTIVELY REVIEWED THE CHARTS OF 34 PATIENTS (24 MALE, 10 FEMALE; MEAN AGE 2.2 YEARS) WHO PRESENTED WITH BASILAR ARTERY OCCLUSION AND UNDERWENT ENDOVASCULAR TREATMENT. OF THE 34 PATIENTS, 13 PATIENTS UNDERWENT TREATMENT WITH THE SOLITAIRE AND/OR ADAPT SYSTEM: 11 WITH SOLITAIRE AND 4 WITH ADAPT. THE ARTICLE NOTES THAT THE FOLLOWING OUTCOMES WERE OBSERVED IN THE SOLITAIRE/ADAPT PATIENTS AT 3-MONTHS POST-PROCEDURE: - 4/13 PATIENTS WERE DECEASED