BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2963862 · Received February 15, 2013

    Report

    Report Number
    9616099-2013-00073
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 20, 2012
    Report Date
    December 3, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2013-00072; # 1016427-2013-00020; AND # 9616099-2013-00073.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE (B)(6) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND THAT DURING THE INDEX PROCEDURE DURING POST-DILATION OF THE PRECISE STENT DEPLOYED IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A NEUROLOGICAL EVENT OF TRANSIENT ISCHEMIC ATTACK (TIA). THE ONSET OF THE EVENT WAS SUDDEN AND WAS CHARACTERIZED BY APHASIA. NO INTERVENTION WAS PERFORMED. THE EVENT WAS REPORTED TO BE RELATED TO THE PROCEDURE AND WAS NOT RELATED TO A CORDIS PRODUCT OR ANTICOAGULATION. THE PATIENT'S RECOVERY WAS FULL/NO DEFICIT. THE EVENT OF TIA WAS CAPTURED AS A NOT REPORTABLE COMPLAINT. THE PATIENT WAS REPORTED TO BE SYMPTOMATIC FOR THE PROCEDURE BY THE SITE ALTHOUGH THE NIH AND RANKIN STROKE SCALES WERE REPORTED TO BE 0. THE LESION WAS REPORTED TO BE: AN 80% STENOSIS, 30 MM. IN LENGTH, ABSENT OF THROMBUS, 6 MM. REFERENCE DIAMETER, MILDLY CALCIFIED, SEVERELY TORTUOUS, AND ULCERATED. THE LESION WAS PRE-DILATED. THE RESIDUAL STENOSIS WAS 0%. THE PATIENT HAD A NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THE PATIENT RECOVERED AND WAS DISCHARGED THE DAY AFTER THE PROCEDURE. ADDENDUM: THE BALLOON CATHETER/BC USED TO POST-DILATE WAS AN AVIATOR PLUS 6 X 20 MM. THE PATIENT'S NIH AND RANKIN STROKE SCALES WERE 0 AT DISCHARGE. THE PRODUCTS WERE NOT RETURNED FOR INSPECTION. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCTS MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. TIA OCCURS WHEN THE BLOOD SUPPLY TO PART OF THE BRAIN IS BRIEFLY INTERRUPTED. CERTAIN FACTORS MAY INFLUENCE THE LIKELIHOOD OF ANTICIPATED BARO-RECEPTOR REACTIONS SUCH AS ADVANCED AGE, VENTRICULAR DYSFUNCTION AND GENDER. VESSEL SPASM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INTERVENTIONAL PROCEDURE WHERE DEVICES ARE INTRODUCED INTO THE VASCULATURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2013-00072; # 1016427-2013-00020; AND # 9616099-2013-00073.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: THE CEC ADJUDICATION MINUTES RECEIVED WERE REVIEWED. THE COMMITTEE REPORTED: TIA DISAGREE AS THE FILE IS CURRENTLY CODED. THE TIA EVENT WILL REMAIN CODED AS A NOT REPORTABLE EVENT AS CURRENTLY CODED/CAPTURED. HOWEVER, ADDITIONAL INFORMATION RECEIVED IN THE REPORT INDICATED THAT POST-STENT BALLOON ANGIOPLASTY WAS PERFORMED. THE NEURO-CHECK SHOWED THAT THE PATIENT WAS UNABLE TO SPEAK CLEARLY OR FOLLOW COMMANDS. HE ALSO DEVELOPED HYPOTENSION AND BRADYCARDIA, FOR WHICH ATROPINE AND LEVOPHED WERE ADMINISTERED. AS SUCH, THE ADVERSE EVENT/AE CODES OF HYPOTENSION AND BRADYCARDIA ARE BEING ADDED TO THE FILE AND WILL BE CAPTURED AS REPORTABLE AE'S AGAINST ALL THREE DEVICES IN THE FILE. THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND THAT DURING THE INDEX PROCEDURE DURING POST-DILATION, THE PATIENT EXPERIENCED A NEUROLOGICAL EVENT OF TRANSIENT ISCHEMIC ATTACK (TIA). THE ONSET OF THE EVENT WAS SUDDEN AND WAS CHARACTERIZED BY APHASIA. NO INTERVENTION WAS PERFORMED. THE EVENT WAS REPORTED TO BE RELATED TO THE PROCEDURE AND WAS NOT RELATED TO A CORDIS PRODUCT OR ANTICOAGULATION. THE PATIENT'S RECOVERY WAS FULL/NO DEFICIT. THE PATIENT WAS SYMPTOMATIC FOR THE PROCEDURE. THE TARGET LESION WAS THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (LICA). THE LESION WAS REPORTED TO BE: AN 80% STENOSIS, 30 MM. IN LENGTH, ABSENT OF THROMBUS, 6 MM. REFERENCE DIAMETER, MILDLY CALCIFIED, SEVERELY TORTUOUS, AND ULCERATED. THE LESION WAS PRE-DILATED. THE RESIDUAL STENOSIS WAS 0%. THE PATIENT HAD A NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THE PATIENT RECOVERED AND WAS DISCHARGED THE DAY AFTER THE PROCEDURE. THE BALLOON CATHETER/BC USED TO POST-DILATE WAS AN AVIATOR PLUS 6 X 20 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68388 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15499312

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R 4 MM ANGIOGUARD, AVIATOR PLUS 6.0 X 20 BC