TREVO PROVUE

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE.

Description of Event or Problem

FOLLOWING AN INFUSION OF 24 MILLION UNITS OF TISSUE PLASMINOGEN ACTIVATOR, RECOMBINANT (RTPA), ONE PASS WITH THE SUBJECT RETRIEVAL DEVICE WAS SUCCESSFULLY PERFORMED TO TREAT A RIGHT M1 MIDDLE CEREBRAL ARTERY OCCLUSION. A THROMBOLYSIS IN CEREBRAL ISCHEMIA (TICI) SCORE OF 3 WAS ACHIEVED AFTER TREATMENT. FURTHER, IT WAS FOUND THAT THE CHARACTERISTIC OF THE LESION WAS ATHEROSCLEROTIC. THEREFORE, FOLLOWING BALLOON ANGIOPLASTY, A STENT WAS PLACED ACROSS THE STENOTIC LESION. HOWEVER, THE FINAL TICI SCORE WAS 0. TWI HOURS POST PROCEDURE, THE PATIENT DEVELOPED A SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) IN THE DISTAL AREA OF THE TREATED VESSEL. NO MEDICAL TREATMENT WAS PROVIDED. THE PHYSICIAN STATED THAT THE CAUSE OF THE SICH WAS A REPERFUSION INJURY.

Additional Manufacturer Narrative

EVENT DESCRIPTION WAS UPDATED. RELEVANT TESTS AND LAB DATA WAS ADDED.

Description of Event or Problem

FOLLOWING AN INFUSION OF 24 MILLION UNITS OF TISSUE PLASMINOGEN ACTIVATOR, RECOMBINANT (RTPA), ONE PASS WITH THE SUBJECT RETRIEVAL DEVICE WAS SUCCESSFULLY PERFORMED TO TREAT A RIGHT M1 MIDDLE CEREBRAL ARTERY OCCLUSION. A THROMBOLYSIS IN CEREBRAL ISCHEMIA (TICI) SCORE OF 3 WAS ACHIEVED AFTER TREATMENT. FURTHER, IT WAS FOUND THAT THE CHARACTERISTIC OF THE LESION WAS ATHEROSCLEROTIC. THEREFORE, FOLLOWING BALLOON ANGIOPLASTY, A STENT WAS PLACED ACROSS THE STENOTIC LESION. HOWEVER, THE FINAL TICI SCORE WAS 0. TWO (2) HOURS POST PROCEDURE, THE PATIENT DEVELOPED A SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) IN THE DISTAL AREA OF THE TREATED VESSEL. NO MEDICAL TREATMENT WAS PROVIDED. APPROXIMATELY ONE MONTH POST PROCEDURE THE PATIENT WAS DISCHARGED WITH MODIFIED RANKIN SCALE (MRS) OF 5. THE PHYSICIAN STATED THAT THE CAUSE OF THE SICH WAS A REPERFUSION INJURY AND THE ADVERSE EVENT RELATIONSHIP TO THE SUBJECT DEVICE IS UNDENIABLE.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, HEMORRHAGE IS A KNOWN RISK ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND IS LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED TO THIS EVENT.

Description of Event or Problem

FOLLOWING AN INFUSION OF 24MILION UNITS OF TISSUE PLASMINOGEN ACTIVATOR, RECOMBINANT (RTPA), ONE PASS WITH THE SUBJECT RETRIEVAL DEVICE WAS SUCCESSFULLY PERFORMED TO TREAT A RIGHT M1 MIDDLE CEREBRAL ARTERY OCCLUSION. A THROMBOLYSIS IN CEREBRAL ISCHEMIA (TICI) SCORE OF 3 WAS ACHIEVED AFTER TREATMENT. FURTHER, IT WAS FOUND THAT THE CHARACTERISTIC OF THE LESION WAS ATHEROSCLEROTIC. THEREFORE, FOLLOWING BALLOON ANGIOPLASTY, A STENT WAS PLACED ACROSS THE STENOTIC LESION. HOWEVER, THE FINAL TICI SCORE WAS 0. TWO (2) HOURS POST PROCEDURE, THE PATIENT DEVELOPED A SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) IN THE DISTAL AREA OF THE TREATED VESSEL. NO MEDICAL TREATMENT WAS PROVIDED. APPROXIMATELY ONE MONTH POST PROCEDURE THE PATIENT WAS DISCHARGED WITH MODIFIED RANKIN SCALE (MRS) OF 5. THE PHYSICIAN STATED THAT THE CAUSE OF THE SICH WAS A REPERFUSION INJURY AND THE ADVERSE EVENT RELATIONSHIP TO THE SUBJECT DEVICE IS UNDENIABLE.