BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3377059 · Received September 30, 2013

    Report

    Report Number
    2024168-2013-06223
    Event Type
    Injury
    Date Received
    September 30, 2013
    Date of Event
    September 6, 2013
    Report Date
    September 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: STENT: ACCULINK, (B)(4), LOT 3012561; OTHER: ASPIRIN, CLOPIDOGREL, PROTAMINE; VESSEL CLOSURE: PERCLOSE PROGLIDE; EMBOLIC PROTECTION: EMBOSHIELD NAV6. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE PERCLOSE PROGLIDE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF STROKE IS LISTED AS A KNOWN POTENTIAL PATIENT EFFECT IN THE ACCULINK 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO ACCULINK STENTS WERE IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY (LICA). THE EMBOSHIELD NAV6 WAS DEPLOYED PAST THE LICA, WHERE THERE WAS MODERATE TORTUOSITY DISTAL TO THE LICA. AT THE END OF THE PROCEDURE, THE PATIENT HAD PASSED THE FULL NEUROLOGICAL EXAMINATION. HOWEVER, THERE WAS BLEEDING AT THE FEMORAL ACCESS SITE FOR WHICH PROTAMINE WAS GIVEN. APPROXIMATELY 20 MINUTES POST PROCEDURE, THE PATIENT HAD RIGHT ARM WEAKNESS, SLURRED SPEECH, AND CONFUSION. THE PATIENT WAS UNABLE TO RECALL HIS NAME AND THE CONDITION WAS CONSIDERED A STROKE. A CAROTID DOPPLER CONFIRMED THAT BOTH STENTS WERE PATENT AFTER THE PATIENT HAD STROKE SYMPTOMS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT HAD A CT SCAN AND A NEUROLOGY CONSULT. THE PATIENT WAS TRANSFERRED TO A REHABILITATION FACILITY SIX DAYS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491758 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2092861

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| S