BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1020271 · Received March 25, 2008

    Report

    Report Number
    3004742046-2008-00066
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    November 1, 2007
    Report Date
    March 4, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE STENT WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS / AE: STROKE. TIME OF AE: DURING THE PROCEDURE. IT WAS REPORTED THAT AT THE END OF AN ATTEMPTED RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, WHILE THE STENT DELIVERY SYSTEM WAS IN THE BODY, THE PATIENT EXPERIENCED A STROKE DUE TO AN OCCLUSION, POSSIBLY EMBOLIC, OF THE RIGHT MIDDLE CEREBRAL ARTERY BRANCH WITH SYMPTOMS OF UPPER AND LOWER EXTREMITY WEAKNESS. DUE TO THE SEVERE TORTUOSITY AND STENOSIS, THE EMBOLIC PROTECTION DEVICES AND STENTS WERE UNABLE TO CROSS THE LESION. THE PHYSICIAN ATTEMPTED, UNSUCCESSFULLY, TO PLACE AN RX ACCUNET AND A NON-ABBOTT FILTER AS WELL AS TWO DIFFERENT SIZES OF RX ACCULINK STENTS. HOWEVER, THE LESION WAS ABLE TO BE DILATED WITH A VIATRAC BALLOON. THE SIZE AND LOCATION OF THE OCCLUDED RIGHT MCA BRANCH, THE TORTUOSITY OF THE CERVICAL INTERNAL CAROTID ARTERY AND THE PATIENTS HISTORY OF SUBACUTE INFARCTS WERE THE DECIDING FACTORS TO ABORT THE PROCEDURE AND NOT TO DO THROMBOLYTICS. EIGHT DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE. STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| S 6F SHUTTLE SHEATH| 0.035" ANGLED GLIDE WIRE| RX ACCULINK 6-8/30| BALANCE HEAVY WEIGHT MICROWIRE| 6F SHEATH| 5F SIMMONS II| HEPARIN| NON-ABBOTT FILTER| RX ACCUNET 5.5| 5F TORCON VERTICLE| VIATRAC 4.5X30