BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MO.MA

    MDR report key: 4043830 · Received August 28, 2014

    Report

    Report Number
    3004066202-2014-00148
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    September 12, 2013
    Report Date
    July 30, 2014
    Manufacturer
    INVATEC SPA
    Product Code
    NTE
    PMA / PMN Number
    K092177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: LIMITED INFORMATION AVAILABLE. INHERENT RISK OF PROCEDURE (MYOCARDIAL INFRACTION). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED- DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. NO DEVICE RETURNED. EVALUATION CONCLUSION: LIMITED INFORMATION AVAILABLE. INHERENT RISK OF PROCEDURE (MYOCARDIAL INFRACTION). UNABLE TO CONFIRM COMPLAINT - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (B)(4).

    Description of Event or Problem · 1

    THIS AIM OF THIS STUDY WAS TO ANALYZE THE CLINICAL EFFICIENCY, SAFETY, AND TECHNICAL FEASIBILITY OF CAROTID ARTERY STENTING (CAS) SURGERY IN THE TREATMENT OF CAROTID ARTERY STENOSIS. BETWEEN (B)(6) 2001 TO (B)(6) 2010, 362 PATIENTS WITH CAROTID ARTERY STENOSIS WHO MET THE INCLUSION AND EXCLUSION CRITERIA AND UNDERWENT CAS WERE RECRUITED IN OUR STUDIES. AMONG THEM, 237 (62.53%) CASES WERE SYMPTOMATIC CAROTID ARTERY STENOSIS AND 142 (37.4%) WERE NON SYMPTOMATIC. IN ALL, 197 PATIENTS HAD TYPICAL CEREBRAL INFARCTION HISTORY ACCOMPANIED WITH VARIOUS SEQUELAE SUCH AS DYSTONIA AND SPEECH DISORDER. COMPLETE TREATMENT AND FOLLOW-UP DATA FROM THIS COHORT WERE PROSPECTIVELY COLLECTED AND ANALYSED RETROSPECTIVELY. A TOTAL OF 379 CASES OF CAROTID ARTERY CAS SURGERIES PERFORMED, OF WHICH 17 CASES WERE NON IPSILATERAL CAROTID STENOSIS, AND THE OTHERS WERE IPSILATERAL STENOSIS. CLINICAL COURSE WAS 1 TO 6 MONTHS. CAROTID ARTERY STENTING WAS PERFORMED ACCORDING TO THE PUBLISHED GUIDELINES. AT LEAST 3 DAYS BEFORE THE PROCEDURE, PATIENTS WERE GIVEN ORAL CLOPIDOGREL 75 MG/D, ENTERIC-COATED ASPIRIN 100 TO 150 MG/D, AND ATORVASTATIN 20 TO 60 MG/NIGHT. WITH REGARD TO THE PATIENTS WITH CAROTID ARTERY VULNERABLE PLAQUES, AGGRESSIVE LIPID-LOWERING TRIALS WERE RECOMMENDED FOR 5 TO 10 DAYS PREVIOUSLY. PLAQUES WITH THIN-CAP FIBROATHEROMA OR RUPTURED FIBER CAP WERE DEFINED AS VULNERABLE PLAQUES THAT WERE MEASURED BY VASCULAR ULTRASOUND COMBINED WITH HIGH-RESOLUTION MAGNETIC RESONANCE IMAGING. MOREOVER, THE PATIENTS WHO HAD ATRIOVENTRICULAR BLOCK OR BRADYCARDIA THAT WERE OVER GRADE WERE REQUIRED TO HAVE AN ATROPINE IRRITATION TEST BEFORE STENTING, AND PRESET TEMPORARY PACEMAKERS WOULD BE EMPLOYED IF NECESSARY. DURING THE OPERATION, PATIENTS WERE SUBJECTED TO LOCAL ANESTHESIA AND SEDATION, THEN 20 TO 30 MG HEPARIN WAS INTRAVENOUSLY INJECTED TO ANTICOAGULATE AND ACCELERATED CLOTTING TIME WAS ADJUSTED TO MORE THAN 180 SECONDS. WHEN IT WAS READY TO PERFORM BALLOON PRELIMINARY DILATION, 0.5 TO 1 MG ATROPINE WAS INTRAVENOUSLY ADMINISTRATED TO ELEVATE HEART RATE TO ABOVE 80 TIMES/MIN IN ORDER TO PREVENT REFLEX BRADYCARDIA OR ASYSTOLE. MEANWHILE, NITROGLYCERIN WAS APPLIED TO REDUCE BLOOD PRESSURE TO THE LOWEST LEVEL WITHIN NORMAL BLOOD PRESSURE RANGE OF EACH PATIENT. IN ORDER TO AVOID THE DRASTIC FLUCTUATIONS IN INTRACRANIAL BLOOD PRESSURE INDUCED BY HIGH-PRESSURE SYRINGE FOR DIGITAL SUBTRACTION ANGIOGRAPHY (DSA), THE RE-EXAMINATION PRESSURE OF HIGH-PRESSURE SYRINGE AFTER CAS SURGERY WAS ADJUSTED TO 150 TO 200 PSI WHILE CONTRAST AGENT WAS 3 ML/S AND SUSTAINED FOR 2.55 SECONDS. FILTER-TYPE EMBOLIC PROTECTION DEVICES WERE USED DURING THE CAS PROCEDURES IN 247 PATIENTS, AND 115 PATIENTS WERE TREATED WITHOUT CEREBRAL PROTECTION DEVICES. ACCORDING TO PHYSICIAN PREFERENCE AND COMMERCIAL AVAILABILITY, MOMA AND SPIDER (EV3, (B)(4)) EMBOLIC PROTECTION SYSTEM, ALONE OR IN COMBINATION, WERE USED IN THIS STUDY. AFTER THE STENT PROCEDURE, ALL PATIENTS WERE TRANSFERRED TO THE NEUROINTENSIVE CARE UNIT FOR OVERNIGHT OBSERVATION. SYMPTOMATIC THERAPY WAS EMPLOYED TO MANAGE THE HEMODYNAMIC CHANGES IN PATIENTS. IF BRADYCARDIA AND OTHER COMPLICATIONS APPEARED, ATROPINE OR SALBUTAMOL WAS APPLIED. BLOOD PRESSURE WAS MONITORED AND CONTROLLED IN THE PREDETERMINED RANGE, AND ALL PATIENTS RECEIVED INTRAVENOUS DRIP OF HEPARIN (50 ML/D) FOR 2 DAYS. THE CONTINUATION OF ANTIPLATELET THERAPY FOR MORE THAN 4 WEEKS AFTER THE PROCEDURE WAS RECOMMENDED FOR ALL PATIENTS WHO HAD UNDERGONE CAS. ASPIRIN (100-150 MG/D) AND CLOPIDOGREL (75 MG/D) WERE GIVEN FOR 12 WEEKS AFTER SURGERIES AND THEN THE ADMINISTRATION OF ASPIRIN AT A DOSE OF 100 TO 150 MG/D WAS SUSTAINED FOR 1 YEAR OR MORE. PATIENTS RECEIVED MEDICAL THERAPY THAT WAS CONSISTENT WITH THE CURRENT STANDARD OF CARE, INCLUDING TREATMENT OF HYPERTENSION AND HYPERLIPIDEMIA. IN THE PERIOPERATIVE PERIOD (30 DAYS), 53 PATIENTS HAD 72 MEDICAL COMPLICATIONS. THREE HUNDRED SEVENTY NINE (379) CAS SURGERIES, INCLUDING 1.58% (6 CASES) OF CEREBRAL HEMORRHAGE, 1.85% (7 CASES) OF CEREBRAL INFARCTION, 1.32% (5 CASES) OF TIA, 0.53% (2 CASES) OF MONOCULAR VISION LOSS ON SURGERY SIDE, 0.79% (3 CASES) OF ANGINA PECTORIS, 1.32% (5 CASES) OF HEART FAILURE, 2.63% (10 CASES) OF SYMPTOMATIC HYPERTENSION, 5.54% (21 CASES) OF SYMPTOMATIC HYPOTENSION, 2.63% (10 CASES) OF SYMPTOMATIC BRADYCARDIA, 0.53% (2 CASES) OF GASTROINTESTINAL BLEEDING, AND 0.26% (1 CASE) OF ANTIPLATELET DRUG SHORTAGE; 15 PATIENTS HAD AT LEAST 2 COMPLICATIONS. A TOTAL OF 27 CASES OF COMPLICATIONS WERE INCLUDED IN THE 30- DAY END POINT EVENTS WITH A RATE OF 7.12%. STROKE PRESENTED IN 17 (4.69%) PATIENTS, INCLUDING 5 (1.32%) CASES OF MAJOR STROKE AND 12 (3.17%) CASES OF MINOR STROKE. MEANWHILE, 4 (1.05%) CASES OF MI (INCLUDING MI AND SUBENDOCARDIAL MI) WERE DETECTED. IN ALL, 6 (1.58%) DEATHS OCCURRED WITHIN 30 DAYS POSTOPERATIVELY; OF WHICH 3 DEATHS WERE DUE TO CEREBRAL HEMORRHAGE, 1 DUE TO PULMONARY EDEMA, 1 DUE TO SYMPTOMATIC HYPERTENSION SUPERVENED WITH CEREBRAL HEMORRHAGE, AND FINALLY 1 DUE TO PULMONARY EMBOLISM. AFTER CAS, 6 CASES OF CEREBRAL HEMORRHAGE OCCURRED, 4 OF WHICH HAPPENED WITHIN 24 HOURS AFTER THE PROCEDURE AND 2 CASES OCCURRED WITHIN 1 WEEK, WHILE 3 PATIENTS WITH CEREBRAL HEMORRHAGE DIED DUE TO NO RESPONSE TO TREATMENTS. NO SURGICAL PROCEDURE-RELATED DEATH OCCURRED IN THE 3 TO 36 MONTHS FOLLOW-UP. HOWEVER, 3 (0.79%) CASES OF STROKE OCCURRED IN OPERATED SIDES AND 10 (2.63%) PATIENTS HAD ASYMPTOMATIC RESTENOSIS ( 50%). THE DSA EVALUATION SHOWED THAT OF THEM 3 PATIENTS HAD 80% INTRASTENT RESTENOSIS WITH PSV >270 CM/S, AS A SEQUENCE, CAS WAS REQUIRED AGAIN AND NO OBVIOUS RESTENOSIS HAPPENED 1 TO 3 YEARS AFTERWARD. CONCLUSION ADVANCED AGE, DIABETES, AND HYPERTENSION INCREASE THE RISK OF POSTOPERATIVE COMPLICATIONS, ESPECIALLY FOR PATIENTS WITH STROKE. THE CHARACTERISTIC OF PLAQUES AND CHOLESTEROL-LOWERING THERAPY SHOULD BE CONSIDERED DURING CAS. IN ADDITION, SEVERE CAROTID ARTERY STENOSIS DOES NOT INCREASE THE INCIDENCE OF 30-DAY END POINT EVENTS. IN ORDER TO CONFIRM INFARCTION, LESIONS WERE REPAIRED EFFECTIVELY AND PERIOPERATIVE CARDIAC AND RENAL FUNCTION PARAMETERS SHOULD BE ADJUSTED TO A CERTAIN LEVEL TO REDUCE THE SURGICAL RISK, HOWEVER, THIS REQUIRES FURTHER PROOF. THEREFORE, MORE EFFORTS ARE ENCOURAGED TO INVESTIGATE SPECIAL TREATMENT TO REDUCE THE OCCURRENCE OF COMPLICATIONS AFTER CAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525539 MO.MA CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR