BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1053326 · Received May 22, 2008

    Report

    Report Number
    9616099-2008-01379
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 13, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AFTER POST-DILATION OF THE STENT AND REMOVAL OF THE ANGIOGUARD DEVICE, THE PATIENT BECAME HYPOTENSIVE WITH PRESSURES OF 70 TO 80. THE HYPOTENSION WAS TREATED WITH FLUID BOLUS AND WAS SUBSEQUENTLY MAINTAINED TO A PRESSURE GREATER THAN 90 WITH PRESSORS. THE PATIENT IS A FEMALE PATIENT WHO WAS CONSENTED TO THE STUDY IN 2008. THE INDEX PROCEDURE WAS COMPLETED ON TEN DAYS LATER, AND PATIENT WAS SYMPTOMATIC. THE TARGET LESION LOCATION WAS THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. REFERENCE VESSEL DIAMETER WAS 4.5MM. TARGET LESION DIAMETER STENOSIS WAS 90%. THE PHYSICIAN MADE ACCESS IN THE RIGHT GROIN. AN ARCH AORTOGRAM AND SELECTIVE CEREBRAL ANGIOGRAPHY WAS PERFORMED. THIS STUDY REVEALED A SIGNIFICANT STENOSIS OF THE RIGHT INTERNAL CAROTID ARTERY (ICA). THERE WAS AN OCCLUSION IN THE CONTRALATERAL CAROTID. A 7FR ANGIOGUARD DISTAL PROTECTION DEVICE WAS ADVANCED AND DEPLOYED DISTAL TO THE AREA OF STENOSIS. THE PATIENT WAS PRE-TREATED WITH 0.5 ATROPINE. A 4X2 AVIATOR BALLOON WAS ADVANCED TO THE AREA OF STENOSIS AND INFLATED TO 6 ATMOSPHERES (ATMS) OF PRESSURE. DURING THIS PRE-DILATION IT BECAME OBVIOUS THAT THERE WAS A CRITICAL AREA OF STENOSIS PRESENT BY THE WAIST ON THE BALLOON. THE BALLOON WAS REMOVED AND A 8MM X 40CM PRECISE STENT WAS DEPLOYED AT THE LESION. THE STENT WAS THEN POST-DILATED WITH A 5MM X 2CM AVIATOR BALLOON. DURING THIS POST-DILATION, THE PATIENT DEVELOPED SEIZURE-LIKE ACTIVITY. THE PHYSICIAN IMMEDIATELY REMOVED THE BALLOON AND THE ANGIOGUARD. THE SEIZURE ACTIVITY RESOLVED AND THE PATIENT BECAME AWAKE AND ALERT. THE PATIENT DID HAVE LOW BLOOD PRESSURES WITH PRESSURES OF 70 TO 80. THE HYPOTENSION TREATED WITH FLUID BOLUS AND SUBSEQUENTLY MAINTAINED TO A PRESSURE GREATER THAN 90 WITH PRESSORS. A FINAL ANGIOGRAM SHOWED EXCELLENT RESULT WITH ONLY A 5% RESIDUAL STENOSIS. THE PATIENT WAS AWAKE, AND NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENT (NIM) NIM CORDIS DE MEXICO NA 13289372

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 7FR. ANGIOGUARD DISTAL PROTECTION DEVICE| 4MM X 2CM AVIATOR| 5MM X 2CM AVIATOR BALLOON