BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3102361 · Received May 9, 2013

    Report

    Report Number
    9616099-2013-00277
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 5, 2013
    Report Date
    April 24, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PLACEMENT OF A PRECISE STENT IT WAS NOTED THAT DUE TO THE TIGHTNESS OF THE LESION THE PHYSICIAN EXPERIENCED DIFFICULTY DEPLOYING THE STENT AND THE STENT WAS NOT ACCURATELY PLACED. A SECOND PRECISE STENT WAS PLACED TO COVER THE ENTIRE LESION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PATIENT IS A (B)(6) MALE WHO WAS ENROLLED IN (B)(4) FOR STENTING OF THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THE VESSEL WAS DESCRIBED AS MILDLY CALCIFIED AND SEVERELY TORTUOUS WITH A STENOSIS OF 90%. AN ANGIOGUARD WAS ADVANCED AND DEPLOYED DISTAL TO THE LESION, THE LESION WAS PRE-DILATED FOLLOWED BY DEPLOYMENT OF A PRECISE STENT. HOWEVER, IT WAS NOTED THAT BECAUSE OF THE TIGHTNESS OF THE LESION THERE WAS SOME DIFFICULTY DEPLOYING THE STENT RESULTING IN THE STENT BEING PLACED A LITTLE DISTALLY AND IT DID NOT COMPLETELY COVER THE LESION. THEREFORE A SECOND PRECISE STENT WAS DEPLOYED TO FULLY COVER THE LESION. THE ANGIOGUARD WAS SAFELY REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE AND WAS DISCHARGED THE NEXT DAY. 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 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. WITH THE INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING PLACEMENT OF A PRECISE STENT, IT WAS NOTED THAT DUE TO THE TIGHTNESS OF THE LESION THE PHYSICIAN EXPERIENCED DIFFICULTY DEPLOYING THE STENT AND THE STENT WAS NOT ACCURATELY PLACED. A SECOND PRECISE STENT WAS PLACED COVER THE ENTIRE LESION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PATIENT IS A (B)(6) MALE WHO WAS ENROLLED IN (B)(4) STUDY FOR STENTING OF THE CAROTID ARTERY. THE TARGET LESION LOCATION WAS PROXIMAL LEFT INTERNAL CAROTID ARTERY. THE VESSEL WAS DESCRIBED AS MILDLY CALCIFIED AND SEVERELY TORTUOUS. THE RATE OF STENOSIS WAS 90% AND LENGTH OF THE LESION WAS 20MM. AN ANGIOGUARD WAS ADVANCED AND DEPLOYED DISTAL TO THE LESION. THE LESION WAS PRE-DILATED AND A PRECISE (PC0930RXC/ LOT 15597714) STENT WAS ADVANCED AND DEPLOYED BUT BECAUSE OF THE TIGHTNESS OF THE LESION THERE WAS SOME DIFFICULTY DEPLOYING THE STENT. THE STENT WAS A LITTLE OVERSHOT AND DID NOT COMPLETELY COVER THE LESION. THEREFORE, A SECOND PRECISE STENT WAS DEPLOYED. THE ANGIOGUARD WAS SAFELY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. APPROXIMATELY SIX WEEKS POST INDEX PROCEDURE THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS DUE TO MULTI SYSTEM ORGAN FAILURE. MAINLY RELATED TO COLON CANCER. SHE STATED THAT THE PATIENT'S DEATH WAS UNRELATED TO THE CORDIS PRODUCT AND INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203870 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15597714

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| L| R