MICRO DRIVER RX

Description of Event or Problem

A JOURNAL ARTICLE WAS SUBMITTED FOR REVIEW TITLED "SAFETY AND EFFICACY OF BALLOON-MOUNTED STENT IN THE TREATMENT OF SYMPTOMATIC INTRACRANIAL ATHEROSCLEROTIC DISEASE: A MULTICENTER EXPERIENCE". THIS STUDY WE AIMED TO IDENTIFY THE SAFETY OF AND EARLY OUTCOMES WITH THE USE OF BALLOON MOUNTED STENTS IN THE TREATMENT OF SYMPTOMATIC INTRACRANIAL ATHEROSCLEROTIC DISEASE (ICAD). PROSPECTIVELY MAINTAINED DATABASES FROM 15 NEUROENDOVASCULAR CENTERS BETWEEN 2010 AND 2020 WERE REVIEWED. A TOTAL OF 232 PATIENTS WERE ELIGIBLE FOR THE ANALYSIS. TWO TYPES OF BALLOON MOUNTED STENT, THE DRUG-ELUTING STENT (DES) AND THE BARE METAL STENT WERE USED IN THE STUDY. DES WAS USED IN 144 (62.1%) PATIENTS, WHEREAS A BARE METAL STENT WAS USED IN 88 (37.9%) PATIENTS. THE FOLLOWING MEDTRONIC DEVICES WERE USED IN THE STUDY: THE MICRODRIVER BARE METAL STENT, RESOLUTE INTEGRITY DES, RESOLUTE ONYX DES AND ENDEAVOR DES. MULTIPLE BRANDS OF NON-MEDTRONIC BARE METAL AND DES WERE ALSO USED. SYMPTOMATIC INTRACRANIAL STENOTIC LESIONS WERE LOCATED IN THE ANTERIOR CIRCULATION IN 135 (58.2%) OF PATIENTS AND IN THE POSTERIOR CIRCULATION IN 97 (41.8%) OF PATIENTS. ANTERIOR CIRCULATION LESIONS TREATED INCLUDED THE SUPRACLINOID-INTERNAL CAROTID ARTERY (ICA), CAVERNOUS-ICA 14, PETROUS-ICA, MIDDLE CEREBRAL ARTERY M1-SEGMENT AND M2-SEGMENT. POSTERIOR CIRCULATION LESIONS TREATED INCLUDED THE VERTEBRAL ARTERY V4-SEGMENT, BASILAR ARTERY AND POSTERIOR CEREBRAL ARTERY. THE PRIMARY OUTCOME WAS THE OCCURRENCE OF STROKE (ISCHEMIC/ HEMORRHAGIC) AND MORTALITY WITHIN 72 HOURS OF THE PROCEDURE. SECONDARY OUTCOMES INCLUDED THE OCCURRENCE OF IPSILATERAL STROKE (ISCHEMIC/HEMORRHAGIC), TRANSIENT ISCHEMIC ATTACK (TIA), AND MORTALITY ON LONG-TERM FOLLOW-UP. ALSO, SECONDARY OUTCOMES INCLUDED RATES OF PROCEDURAL FAILURE DEFINED AS FAILURE TO DEPLOY THE STENT AT THE TARGET ARTERY. PROCEDURAL COMPLICATIONS OCCURRED IN TWO CASES. A DISSECTION OCCURRED IN ONE CASE THAT LED TO BRAIN STEM INFARCTION AND LOCKED-IN SYNDROME. A PERFORATION OF A POSTERIOR COMMUNICATING ARTERY ANEURYSM IN THE OTHER CASE THAT LED TO SUBARACHNOID HEMORRHAGE AND PATIENT DEATH. WITHIN 72 HOURS POST-STENTING, STROKE WAS REPORTED IN 13 (5.6%) PATIENTS INCLUDING 9 (3.9%) IPSILATERAL ISCHEMIC EVENTS (RESULTING IN 6 (2.6%) PERMANENT AND 3 (1.3%) TEMPORARY NEUROLOGICAL DEFICITS) AND 4 (1.7%) HEMORRHAGIC STROKES. THERE WERE NO REPORTED CASES OF PROCEDURAL FAILURE. THERE WERE TWO DEATHS ON DISCHARGE, 1 FROM BRAIN STEM INFARCTION AND 1 FROM THE SUBARACHNOID HEMORRHAGE. A TOTAL OF 189 PATIENTS HAD A FOLLOW-UP WITH A MEDIAN TIME OF 6 (3¿14.5) MONTHS, IN WHOM TRANSIENT ISCHEMIC ATTACKS AND IPSILATERAL STROKES (ISCHEMIC/HEMORRHAGIC) WERE REPORTED IN 12 (6.3%) AND 7 (3.7%), RESPECTIVELY. THREE PATIENTS (1.6%) DIED FROM NON-STROKE RELATED COMPLICATIONS, 1 FROM METASTATIC CANCER AND 2 FROM END STAGE RENAL DISEASE. ON FOLLOW-UP IMAGING OF 133 PATIENTS (70 DES AND 63 BARE METAL STENT), IN STENT RESTENOSIS (ISR) WAS IDENTIFIED IN 33 (24.8%) PATIENTS (15/70 (21.4%) DES AND 18/63 (28.6%) BARE METAL STENT). SYMPTOMATIC ISR WAS REPORTED IN 15 (11.3%) PATIENTS (7/70 (10%) DES AND 8/63 (12.7%) BARE METAL STENT), OF WHICH 11 WERE TREATED WITH STENTING (N=5) OR ANGIOPLASTY (N=6).

Additional Manufacturer Narrative

MAHMOUD H MOHAMMADEN, RAUL G NOGUEIRA, WONDWOSSEN TEKLE, SANTIAGO ORTEGA-GUTIERREZ, MUDASSIR FAROOQUI, CYNTHIA B. ZEVALLOS, RICARDO A HANEL, GUSTAVO M CORTEZ, AMIN AGHAEBRAHIM, ROBERT M STARKE, HANY AREF, AHMED ELBASSIOUNY, AYMAN GAMEA, ALI ALARAJ, MORTEZA SADEH, MIKAYEL GRIGORYAN, OKKES KUYBU, DIOGO C HAUSSEN, SUNIL A SHETH, ALBERTO MAUD, STEVE M CORDINA, OMAR TANWEER, PETER KAN, JAN-KARL BURKHARDT, RAMESH GRANDHI, FARHAN SIDDIQ, AMEER E HASSAN "SAFETY AND EFFICACY OF BALLOON-MOUNTED STENT IN THE TREATMENT OF SYMPTOMATIC INTRACRANIAL ATHEROSCLEROTIC DISEASE: A MULTICENTER EX PERIENCE" JOURNAL OF NEUROINTERVENTIONAL SURGERY 2022;14:756¿761. HTTP://DX.DOI.ORG/10.1136/NEURINTSURG2021-017818 A2: AVERAGE AGE A3: MAJORITY GENDER A5B: AVERAGE PATIENT RACE B3: DATE OF PUBLICATION NO UNIQUE DEVICE IDENTIFIER (LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. THERE IS NO ESTABLISHED OR SUSPECTED CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE DEATH EVENTS. DEATHS ARE COMMON OCCURRENCES IN CLINICAL STUDIES, HOWEVER THE CAUSE(S) OF DEATH ARE OFTEN NOT CHARACTERIZED OR CLEARLY ASSOCIATED WITH A PARTICULAR PRODUCT. THEREFORE, DEATHS WILL NOT BE CONSIDERED REPORTABLE UNLESS CLEARLY STATED AS BEING ASSOCIATED WITH A MEDTRONIC DEVICE. 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.

Additional Manufacturer Narrative

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.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE MEDTRONIC DEVICES AND THE ADVERSE EVENTS AND DEATHS REPORTED. 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.