BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2884196 · Received December 21, 2012

    Report

    Report Number
    2024168-2012-08285
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 3, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS. THE PREMATURE DEPLOYMENT WAS ABLE TO BE CONFIRMED. THE FAILURE TO ADVANCE AND STENT MIGRATION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE PATIENT EFFECTS OF CEREBROVASCULAR ACCIDENT, EMBOLISM, PERFORATION, AND HYPOTENSION, AS LISTED IN THE POTENTIAL ADVERSE EVENTS SECTION OF THE RX ACCULINK CAROTID STENT SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MODERATELY CALCIFIED LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE STENT DELIVERY SYSTEM FAILED TO REACH THE TARGET LESION AND BEFORE UNLOCKING THE STENT DELIVERY SYSTEM, THE RX ACCULINK STENT DEPLOYED IN THE LEFT INTERNAL CAROTID AND FLOATED BACK THROUGH THE ARTERY INTO THE COMMON CAROTID. SNARING WAS ATTEMPTED THROUGH THE GUIDING CATHETER; HOWEVER, SINCE IT WAS EXPANDED, IT COULD NOT BE PULLED THROUGH THE CATHETER, SO THE CATHETER WAS REMOVED AND THE DISLODGED STENT WAS REMOVED DIRECTLY THROUGH THE VASCULATURE RESULTING IN A LACERATED SUPERFICIAL FEMORAL ARTERY AND A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WAS NO STENT IMPLANTED AND POST PROCEDURE STENOSIS WAS 40%. POST PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION AND DOPAMINE AND NEOSYNEPHRINE WERE GIVEN TO SUPPORT THE BLOOD PRESSURE. ADDITIONALLY, EMERGENCY SURGICAL VASCULAR REPAIR WAS PERFORMED, REPAIRING THE LACERATED ARTERY. APPROXIMATELY 6 HOURS POST PROCEDURE, ON (B)(6) 2012, THE PATIENT REPORTED DIPLOPIA, WHICH WAS TREATED WITH HEPARIN. PER MAGNETIC RESONANCE IMAGING, AN ISCHEMIC AREA WAS SEEN IN THE LEFT TEMPORAL OCCIPITAL AREA OF THE BRAIN. THE EVENT WAS DIAGNOSED AS AN EMBOLIC STROKE WITH LOSS OF A VISUAL FIELD. THE PATIENT REMAINS HOSPITALIZED, BUT ON (B)(6) 2012, WAS MOVED FROM THE INTENSIVE CARE UNIT. THERE WAS NO ADDITIONAL INFORMATION 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 2051761

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R| S EMBOLIC PROTECTION: EMBOSHIELD NAV6 7.2MM, 190CM