BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2882604 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08229
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EMBOLIC PROTECTION: EMBOSHIELD NAV6. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF CEREBROVASCULAR ACCIDENT, INTRACRANIAL HEMORRHAGE, AND NEUROLOGICAL DEFICIT DYSFUNCTION ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE RX ACCULINK CAROTID STENT SYSTEM INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF CEREBROVASCULAR ACCIDENT, INTRACRANIAL HEMORRHAGE, AND NEUROLOGICAL DEFICIT DYSFUNCTION ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE RX ACCULINK CAROTID STENT SYSTEM INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT A STENTING PROCEDURE WITH PLACEMENT OF AN EMBOSHIELD NAV6 AT THE TARGET SITE IN THE MODERATELY CALCIFIED LEFT INTERNAL CAROTID ARTERY. A 7-10 X 40 MM ACCULINK STENT DELIVERY SYSTEM WAS THEN ADVANCED TO THE TARGET LESION AND THE STENT DEPLOYED. 12 HOURS POST STENTING PROCEDURE, MENTAL STATUS CHANGES WERE NOTED UPON A NEUROLOGICAL EXAM. THE PATIENT NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) WAS 16. A STROKE WAS DIAGNOSED AND CONFIRMED WITH COMPUTED TOMOGRAPHY. ADDITIONAL INTERVENTION WAS PERFORMED TO EVACUATE THE HEMATOMA IN THE BRAIN. THE PATIENT CONDITION CONTINUES. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT IS NON-RESPONSIVE TO VERBAL OR PHYSICAL STIMULATION. THE PATIENT MOVES THE LEFT SIDE RANDOMLY, BUT HE IS NOT MOVING HIS RIGHT SIDE AT ALL. THE PATIENT REMAINS HOSPITALIZED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT FILED ON (B)(4) 2012, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ON (B)(6) 2012, THE PATIENT UNDERWENT A TRACHEOSTOMY RELATED TO PROLONGED VENTILATOR DEPENDENCE DUE TO RESPIRATORY INSUFFICIENCY AS A RESULT OF STROKE. ON (B)(6) 2012, THE PATIENT HAD A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACED TO FACILITATE TUBE FEEDINGS AS THE PATIENT WAS UNABLE TO TAKE ORAL NUTRITION. ON (B)(6) 2012, THE PATIENT UNDERWENT A CRANIOPLAST PROCEDURE TO REPAIR A CRANIAL DEFECT AND A CEREBROSPINAL FLUID FISTULA. THE PATIENT WAS DISCHARGED ON (B)(6) 2013 TO A SKILLED NURSING FACILITY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2011861

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R| S CONCOMITANT MEDICAL DEVICES