BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3162442 · Received June 11, 2013

    Report

    Report Number
    9616099-2013-00362
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 29, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING POST-DILATION OF THE PRECISE STENT, THE PATIENT EXPERIENCED AN ADVERSE EVENT/AE OF TRANSIENT ISCHEMIC ATTACK/TIA. THE PATIENT EXPERIENCED APHASIA, REFLEX CHANGE AND HEMIPARESIS ON THE RIGHT SIDE. DURATION OF NEUROLOGICAL DEFICIT WAS <24 HOURS. ONSET WAS SUDDEN AND RECOVERY WAS FULL WITH NO DEFICIT. NO INTERVENTION/EMERGENCY CEA SURGERY WAS PERFORMED AS A RESULT OF THE AE. THE TARGET LESION WAS REPORTED TO BE: A 90% STENOSIS, 20 MM. IN LENGTH, ABSENT OF THROMBUS, 5 MM. REFERENCE DIAMETER, NOT CALCIFIED, MODERATELY TORTUOUS, AND ULCERATED. THE LESION WAS PRE-DILATED. THE RESIDUAL STENOSIS WAS 10%. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND REVIEWED. THE ADJUDICATION MINUTES RECEIVED INDICATED THAT THE COMMITTEE AGREED WITH THE REPORTED ADVERSE EVENT (AE) OF TIA AS PROCEDURE/DEVICE RELATED. THE PATIENT RECOVERED FULLY FROM THE EVENT WITH NO RESIDUAL EFFECT. HOWEVER, A FOLLOW-UP CEREBRAL ANGIOGRAM WAS PERFORMED AFTER THE INDEX PROCEDURE. AT THAT TIME, THE PATIENT WAS COMPLETELY NEUROLOGICALLY INTACT. THE CATHETERIZATION REPORT NOTED THAT IT WAS FELT THAT HIS NEUROLOGICAL SYMPTOMS WERE NOT RELATED TO THE FILTER OR STENT, BUT TO THE PROCEDURE. THE PATIENT DEVELOPED HYPOTENSION AND WAS GIVEN NEOSYNEPHRINE IV AND WAS PLACED ON A NEOSYNEPHRINE DRIP. HE WAS ALSO ADMINISTERED ATROPINE FOR MILD BRADYCARDIA. THE PRODUCT WAS NOT RETURNED FOR INSPECTION. 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 15736164 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE INFORMATION PROVIDED AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. HYPOTENSION, BRADYCARDIA AND THE RESULTANT TIA RELATED TO CAROTID STENTING IS USUALLY RELATED TO BARO-RECEPTOR STIMULATION. BARORECEPTORS DETECT THE AMOUNT OF STRETCH OF THE BLOOD VESSEL WALLS, AND SEND THE SIGNAL TO THE NERVOUS SYSTEM IN RESPONSE TO THIS STRETCH, INITIATING A REFLEX VIA THE GLOSSOPHARYNGEAL NERVE. THIS RESULTS IN A FALL IN BLOOD PRESSURE AND BRADYCARDIA. STENT PLACEMENT MAY PROMOTE PERSISTENT STIMULATION OF THESE BARO-RECEPTORS. THESE REACTIONS ARE ANTICIPATED RELATIVELY SHORT-TERM ADVERSE EVENTS ASSOCIATED WITH THE COMPRESSION OF THE BARO-RECEPTORS DURING BALLOON INFLATION, STENT IMPLANTATION AND FILTER DEVICE MANIPULATION. ALSO IDENTIFY WHETHER THERE WERE ANY NEUROLOGICAL SYMPTOMS ASSOCIATED WITH THE HYPOTENSION AND BRADYCARDIA. NEUROLOGICAL SYMPTOMS CAN OCCUR AS A RESULT OF DECREASED BLOOD SUPPLY TO THE BRAIN CAUSED BY THE HYPOTENSION/BRADYCARDIA. THESE REACTIONS ARE ANTICIPATED RELATIVELY SHORT-TERM ADVERSE EVENTS. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND REVIEWED. THE ADJUDICATION MINUTES RECEIVED INDICATED THAT THE COMMITTEE AGREED WITH THE REPORTED ADVERSE EVENT (AE) OF TIA AS PROCEDURE/DEVICE RELATED. THE PATIENT RECOVERED FULLY FROM THE EVENT WITH NO RESIDUAL EFFECT. HOWEVER, A FOLLOW-UP CEREBRAL ANGIOGRAM WAS PERFORMED AFTER THE INDEX PROCEDURE. AT THAT TIME, THE PATIENT WAS COMPLETELY NEUROLOGICALLY INTACT. THE CATHETERIZATION REPORT NOTED THAT IT WAS FELT THAT HIS NEUROLOGICAL SYMPTOMS WERE NOT RELATED TO THE FILTER OR STENT, BUT TO THE PROCEDURE. THE PATIENT DEVELOPED HYPOTENSION AND WAS GIVEN NEOSYNEPHRINE IV AND WAS PLACED ON A NEOSYNEPHRINE DRIP. HE WAS ALSO ADMINISTERED ATROPINE FOR MILD BRADYCARDIA. THE REPORT RECEIVED FROM (B)(6) INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND THAT DURING THE STUDY INDEX PROCEDURE, A 6 MM. ANGIOGUARD EMBOLIC PROTECTION DEVICE PREMATURELY DEPLOYED IN THE GUIDING CATHETER/SHEATH. ANOTHER 6 MM ANGIOGUARD WAS USED TO COMPLETE THE PROCEDURE. A PRECISE 9 X 40 STENT WAS SUCCESSFULLY DEPLOYED AT THE INTENDED BIFURCATION LEFT COMMON CAROTID ARTERY TARGET LESION. DURING POST-DILATION OF THE STENT, THE PATIENT EXPERIENCED AN ADVERSE EVENT/AE OF TRANSIENT ISCHEMIC ATTACK/TIA. THE PATIENT EXPERIENCED APHASIA, REFLEX CHANGE AND HEMIPARESIS ON THE RIGHT SIDE. DURATION OF NEUROLOGICAL DEFICIT WAS <24 HOURS. ONSET WAS SUDDEN AND RECOVERY WAS FULL WITH NO DEFICIT. NO INTERVENTION/EMERGENCY CEA SURGERY WAS PERFORMED AS A RESULT OF THE AE. THE TARGET LESION WAS REPORTED TO BE: A 90% STENOSIS, 20 MM. IN LENGTH, ABSENT OF THROMBUS, 5 MM. REFERENCE DIAMETER, NOT CALCIFIED, MODERATELY TORTUOUS, AND ULCERATED. THE LESION WAS PRE-DILATED. THE RESIDUAL STENOSIS WAS 10%. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263000 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15736164

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening| R 6 MM ANGIOGUARD