SOLITAIRE RD
Received Jan 21, 2019 · Event occurred Jun 5, 2017
Report 2029214-2019-00045 · MDR key 8265806
Device
Generic name
Catheter, Thrombus Retriever
Manufacturer
Micro Therapeutics, Inc. Dba Ev3 NeurovascularProduct problems
- Adverse Event Without Identified Device or Use Problem
- No Apparent Adverse Event
- Adverse Event Without Identified Device or Use Problem
- No Apparent Adverse Event
Patient
Not reported
- Death
- Occlusion
- Death
- Occlusion
Narrative
Additional Manufacturer Narrative
THE SOLITAIRE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION. BASED ON THE REPORTED INFORMATION, THERE DOES NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT POST-PROCEDURE AND ITS CAUSE COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
DOBROCKY, T., PIECHOWIAK, E., CIANFONI, A., ZIBOLD, F., ROCCATAGLIATA, L., MOSIMANN, P., . . . GRALLA, J. (2017). THROMBECTOMY OF CALCIFIED EMBOLI IN STROKE. DOES HISTOLOGY OF THROMBI INFLUENCE THE EFFECTIVENESS OF THROMBECTOMY? JOURNAL OF NEUROINTERVENTIONAL SURGERY, 10(4), 345-350. DOI:10.1136/NEURINTSURG-2017-013226 MEDTRONIC LITERATURE REVIEW FOUND REPORTS OF THE FOLLOWING OUTCOMES: PATIENT #6 WAS TREATED FOR A LEFT M2 OCCLUSION WITH A SOLITAIRE 4X20. THE BASELINE NIHSS WAS 24. THE SOLITAIRE MADE 4 PASSES. THE TICI POST THE INTERVENTION WAS 0 AND THE MRS WAS 6 BY THE 3RD MONTH. NO COMPLICATIONS. PATIENT #8 WAS TREATED FOR RIGHT CAROTID T OCCLUSION. THE BASELINE NIHSS WAS 16. A SOLITAIRE 6-30 MADE 3 PASS AND ACHIEVED TICI OF 1. THERE WAS NOTE THAT THE CALCIFIED CLOT WAS PUSHED INTO THE M1 ORIGIN , WHICH RESTORED BLOOD FLOW IN THE ACA TERRITORY. POST THE MECHANICAL INTERVENTION, DECOMPRESSIVE CRANIOTOMY WAS PERFORMED. THE MRS WAS 6 BY THE 3RD MONTH.