BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2151809 · Received July 6, 2011

    Report

    Report Number
    9616099-2011-00467
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 22, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15387032 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15387032. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. AMAUROSIS FUGAX IS LOSS OF VISION IN ONE EYE DUE TO A TEMPORARY LACK OF BLOOD FLOW TO THE RETINA. IT IS THOUGHT TO OCCUR WHEN A PIECE OF PLAQUE IN THE CAROTID ARTERY BREAKS OFF AND TRAVELS TO THE RETINAL ARTERY IN THE EYE. PLAQUE IS A HARD SUBSTANCE THAT FORMS WHEN FAT, CHOLESTEROL, AND OTHER SUBSTANCES BUILD UP IN THE WALLS OF ARTERIES. PIECES OF PLAQUE CAN TRAVEL THROUGH THE BLOODSTREAM. VISION LOSS OCCURS AS LONG AS THE BLOOD SUPPLY TO THE ARTERY IS BLOCKED. ATHEROSCLEROSIS OF THE ARTERIES IN THE NECK IS THE MAIN RISK FACTOR FOR THIS CONDITION. RISK FACTORS FOR ATHEROSCLEROSIS INCLUDE HEART DISEASE, HIGH CHOLESTEROL, SMOKING, DIABETES, AND HIGH BLOOD PRESSURE. SYMPTOMS INCLUDE THE SUDDEN LOSS OF VISION IN ONE EYE. THIS USUALLY ONLY LASTS SECONDS BUT MAY LAST SEVERAL MINUTES. SOME PATIENTS DESCRIBE THE LOSS OF VISION AS A GRAY OR BLACK SHADE COMING DOWN OVER THEIR EYE. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED VIA AN EMAIL ON (B)(4) 2012. THE CEC ADJUDICATION COMMITTEE DETERMINED THAT THE PATIENT HAD EXPERIENCED A STROKE ON (B)(6) 2011 WHEN THE VISUAL AND LEFT-SIDED WEAKNESS HAD OCCURRED. THE INVESTIGATOR HAD REPORTED THIS AS A TIA. THE ACTUAL ADJUDICATION COMMITTEE MEETING MINUTES HAVE NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

    Additional Manufacturer Narrative · 1

    ACTUAL CEC ADJUDICATION MINUTES RECEIVED ON (B)(4) 2012: THE PATIENT EXPERIENCED A STROKE INSTEAD OF TIA. THE INDEX PROCEDURE WAS ON (B)(6) 2012 WITH A PRECISE STENT PLACED IN THE RIGHT PROXIMAL INTERNAL CAROTID ARTERY. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED WITH INTERMITTENT LEFT ARM WEAKNESS AND RIGHT UPPER QUADRANT VISUAL LOSS. THE NEUROLOGY CONSULT REPORT NOTED THAT PATIENT'S SYMPTOMS BEGAN SEVERAL WEEKS PRIOR WITH SUDDEN ONSET OF PARESTHESIA WHICH SUBSIDED AND WAS REPLACED BY PARALYSIS THAT LASTED 30 TO 40 MINUTES. THE PATIENT'S EYE SYMPTOM BEGAN WHEN HE AWOKE FROM THE INDEX PROCEDURE. A CTA OF THE HEAD WITH AND WITHOUT CONTRAST ON (B)(6) 2011 REVEALED SMALL INTRA-LUMINAL FILLING DEFECTS WITHIN THE RIGHT CAROTID ARTERY STENT, NON-OCCLUSIVE, BUT SUSPECT SMALL MURAL THROMBI. THERE WAS A SMALL WAIST IN THE ICA PORTION OF THE STENT WITH LESS THAN 30% STENOSIS COMPARED TO ICA DISTAL TO THE STENT. A CT OF THE BRAIN WITHOUT CONTRAST ON (B)(6) 2011 SHOWED NO ACUTE INTRACRANIAL ABNORMALITIES. THE SITE HAD REPORTED THE DEFICITS AS PERMANENT WITH THE EVENT REPORTED AS A TIA. THE CONSULTATION NOTE REPORTED RECURRENT RIGHT CEREBRAL SYMPTOMS CAUSING LEFT ARM PARALYSIS SECONDARY TO RECURRING EMBOLISM FROM THE RIGHT ICA. THE PATIENT WAS TREATED WITH AGGRESSIVE ANTICOAGULATION WITH WARFARIN. AT THE TIME OF THE 30 DAY FOLLOW-UP, THE NIH STROKE SCALE SCORE WAS 1 AND RANKIN STROKE SCALE SCORE WAS 0.

    Additional Manufacturer Narrative · 1

    UPDATED DHR WAS COMPLETED BASED ON CODE OF STROKE, AND COMPLAINT CONCLUSION WAS UPDATED. COMPLAINT CONCLUSION: IT WAS INITIALLY REPORTED THAT TWO DAYS AFTER HAVING A STENT PLACED IN THE RIGHT INTERNAL CAROTID ARTERY THE PATIENT RETURNED WITH LOSS OF THE TOP HALF OF HIS VISION IN THE RIGHT EYE, AND LEFT ARM WEAKNESS (NOTE THAT THE PATIENT HAD ALREADY HAD LEFT ARM WEAKNESS FOR SEVERAL WEEKS PRIOR TO THE INDEX PROCEDURE). THE PATIENT WAS PUT ON HEPARIN. THE LEFT ARM WEAKNESS CONTINUES TO COME AND GO, HOWEVER THE VISION LOSS HAS NOT IMPROVED. ANGIOGRAPHY DURING THE PATIENT'S STAY AT THE HOSPITAL SHOWED A SMALL MURAL THROMBUS WITHIN THE PRECISE STENT. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, HISTORY OF SMOKING, HYPERTENSION AND LEFT ARE WEAKNESS. ADDITIONAL INFORMATION PROVIDED VIA THE CEC ADJUDICATION COMMITTEE MINUTES REVEALED THAT THE COMMITTEE DETERMINED THE SYMPTOMS TO BE A STROKE. THE NEUROLOGY CONSULT REPORT NOTED THAT PATIENT'S SYMPTOMS BEGAN SEVERAL WEEK PRIOR WITH SUDDEN ONSET OF PARESTHESIA WHICH SUBSIDED AND WAS REPLACED BY PARALYSIS THAT LASTED 30 TO 40 MINUTES. THE PATIENT'S EYE SYMPTOM BEGAN WHEN HE AWOKE FROM THE INDEX PROCEDURE . A CTA OF THE HEAD WITH AND WITHOUT CONTRAST ON (B)(6) 2011 REVEALED SMALL INTRALUMINAL FILLING DEFECTS WITHIN THE RIGHT CAROTID ARTERY STENT, NON-OCCLUSIVE, BUT SUSPECT SMALL MURAL THROMBI. THERE WAS A SMALL WAIST IN THE ICA PORTION OF THE STENT WITH LESS THAN 30% STENOSIS COMPARED TO ICA DISTAL TO THE STENT. A CT OF THE BRAIN WITHOUT CONTRAST ON (B)(6) 2011 SHOWED NO ACUTE INTRACRANIAL ABNORMALITIES. THE CONSULTATION NOTE REPORTED RECURRENT RIGHT CEREBRAL SYMPTOMS CAUSING LEFT ARM PARALYSIS SECONDARY TO RECURRING EMBOLISM FROM THE RIGHT ICA. THE PATIENT WAS TREATED WITH AGGRESSIVE ANTICOAGULATION WITH WARFARIN. AT THE TIME OF THE 30 DAY FOLLOW-UP, THE NIH STROKE SCALE SCORE WAS 1 AND RANKIN STROKE SCALE SCORE WAS 0. DEVICES WERE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. THROMBOSIS CAN CAUSE SERIOUS POST-PROCEDURAL COMPLICATIONS OF STENT OCCLUSION OR DISTAL EMBOLIZATION, RESULTING IN ACUTE CEREBRAL INFARCTION. ACUTE STENT THROMBOSIS RATE IS REPORTED TO BE APPROXIMATELY 0.5%. IN THE CAVITAS ((B)(4) STUDY) TRIAL. SEVERAL FACTORS, INCLUDING MECHANICAL PLAQUE DISRUPTION, INTIMAL INJURY, AND STENT THROMBOGENICITY PREDISPOSE THE PATIENT TO THROMBOEMBOLIC EVENTS. PLATELET ADHESION, ACTIVATION, AND AGGREGATION PLAY MAIN ROLES IN MURAL THROMBUS FORMATION. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE ALERT DATE FOR THE EVENT OF "TRANSIENT ISCHEMIC ATTACK" WAS INADVERTENTLY CAPTURED AS (B)(6) 2011 INSTEAD OF (B)(6) 2011. THEREFORE, THE FILE WILL BE UPDATED CAPTURED THE CORRECT EVENT DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAYS AFTER HAVING A STENT PLACED IN THE RIGHT INTERNAL CAROTID ARTERY THE PATIENT RETURNED WITH LOSS OF THE TOP HALF OF HIS VISION IN THE RIGHT EYE, AND LEFT ARM WEAKNESS (NOTE THAT THE PATIENT HAD ALREADY HAD LEFT ARM WEAKNESS FOR SEVERAL WEEKS PRIOR TO THE INDEX PROCEDURE). THE PATIENT WAS PUT ON HEPARIN. THE LEFT ARM WEAKNESS CONTINUES TO COME AND GO, HOWEVER THE VISION LOSS HAS NOT IMPROVED. ANGIOGRAPHY DURING THE PATIENT'S STAY AT THE HOSPITAL SHOWED A SMALL MURAL THROMBUS WITHIN THE PRECISE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15387032

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 6MM ANGIOGUARD