SOLITAIRE

Additional Manufacturer Narrative

ALBERS, G. W. (2018). THROMBECTOMY FOR STROKE AT 6 TO 16 HOURS WITH SELECTION BY PERFUSION IMAGING. THE NEW ENGLAND JOURNAL OF MEDICINE, 378, 708-718. DOI:10.1056/NEJMOA1713973 THE SOLITAIRE DEVICE HAS 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 SOLITAIRE DURING USE. THE EVENT OCCURRED INT RA-PROCEDURALLY AND THE CAUSE COULD NOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PERFORATION DURING SOLITAIRE THROMBECTOMY. THE ARTICLE DESCRIBES THE DEFUSE 3 CLINICAL TRIAL, WHICH WAS CONDUCTED TO ASSESS THROMBECTOMY IN PATIENTS 6 TO 16 HOURS AFTER THEY WERE LAST KNOWN TO BE WELL AND WHO HAD REMAINING ISCHEMIC BRAIN TISSUE THAT WAS NOT YET INFARCTED. DURING THE TRIAL, 182 PATIENTS UNDERWENT RANDOMIZATION: 92 TO THE ENDOVASCULAR-THERAPY GROUP AND 90 TO THE MEDICAL THERAPY GROUP. OF THE 92 ENDOVASCULAR-THERAPY PATIENTS, 42 UNDERWENT MECHANICAL THROMBECTOMY WITH A SOLITAIRE DEVICE. THE OTHER THROMBECTOMY DEVICES INCLUDED TREVO, PENUMBRA, AND MINDFRAME. THE 92 ENDOVASCULAR THERAPY PATIENTS HAD A MEDIAN AGE OF 70 YEARS; 46 OF THE PATIENTS WERE FEMALE. IT WAS REPORTED TO MEDTRONIC THAT A VESSEL PERFORATION DESCRIBED IN THE MANUSCRIPT OCCURRED IN A SOLITAIRE-TREATED SUBJECT. PER THE MANUSCRIPT, VESSEL PERFORATION RESULTED IN SUBARACHNOID HEMORRHAGE ASSOCIATED WITH A 3-POINT INCREASE IN NIHSS.