BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 2041216 · Received April 6, 2011

    Report

    Report Number
    9616099-2011-00226
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    August 6, 2008
    Report Date
    April 30, 2009
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K041796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY ON (B)(6) 2008 WITH AN 80% LESION IN THE LEFT CAROTID ARTERY. THE LESION WAS MILDLY CALCIFIED, CONCENTRIC AND 7MM IN LENGTH. THE VESSEL WAS MILDLY TORTUOUS AND 4MM IN DIAMETER. THE LESION WAS PRE-DILATED. AN ANGIOGUARD WAS PLACED AND A PRECISE STENT WAS IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS DISCHARGED THE NEXT DAY. APPROXIMATELY TWO MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED RIGHT HEMIPARESIS AND RIGHT HEMIATAXIA. THE ONSET WAS GRADUAL. THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE AND WAS TRANSFERRED TO REHABILITATION FACILITY DUE TO PERSISTENT RIGHT-SIDED WEAKNESS. THE DISCHARGE DIAGNOSIS INCLUDED ACUTE CVA, LEFT CEREBRAL HEMISPHERIC LACUNAR INFARCT WITH RESIDUAL RIGHT-SIDED WEAKNESS AND ATAXIA. THE SITE REPORTED THIS EVENT AS AN ISCHEMIC STROKE AND FURTHER NOTED THAT THE DEFICITS LASTED >24 HOURS BUT FULLY RESOLVING WITHOUT RESIDUAL DEFICITS. 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 13261950 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. ISCHEMIC STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND CAN BE DEFINED AS A CEREBROVASCULAR DISORDER CAUSED BY DEPRIVATION OF BLOOD FLOW TO AN AREA OF THE BRAIN, GENERALLY AS A RESULT OF THROMBOSIS, EMBOLISM, OR REDUCED BLOOD PRESSURE. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    APPROXIMATELY TWO MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED RIGHT HEMIPARESIS AND RIGHT HEMIATAXIA. THE ONSET WAS GRADUAL. THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE PATIENT WAS TRANSFERRED TO REHABILITATION FACILITY DUE TO PERSISTENT RIGHT-SIDED WEAKNESS. THE DISCHARGE DIAGNOSIS INCLUDED ACUTE CVA, LEFT CEREBRAL HEMISPHERIC LACUNAR INFARCT WITH RESIDUAL RIGHT-SIDED WEAKNESS AND ATAXIA. THE SITE REPORTED THIS EVENT AS AN ISCHEMIC STROKE AND FURTHER NOTED THAT THE DEFICITS LASTED GREATER 24 HOURS BUT FULLY RESOLVED WITHOUT RESIDUAL DEFICITS. THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY ON (B)(6) 2008 WITH AN 80% LESION IN THE LEFT CAROTID ARTERY. THE LESION WAS MILDLY CALCIFIED, CONCENTRIC AND 7MM IN LENGTH. THE VESSEL WAS MILDLY TORTUOUS AND 4MM IN DIAMETER. THE LESION WAS PRE-DILATED. AN ANGIOGUARD WAS PLACED AND A PRECISE STENT WAS IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS DISCHARGED THE NEXT DAY. THE PATIENT'S PRE-PROCEDURE MEDICATIONS INCLUDE ASPIRIN AND CLOPIDOGREL. THE PATIENT'S INTRA PROCEDURE MEDICATIONS INCLUDE CLOPIDOGREL. THE PATIENT'S POST PROCEDURE MEDICATIONS INCLUDE ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS (NIM) FGE CORDIS DE MEXICO NA 13261950

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization