BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1840846 · Received September 17, 2010

    Report

    Report Number
    3004742046-2010-00424
    Event Type
    Death
    Date Received
    September 17, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: STROKE AND DEATH MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTIONS FOR USE, STROKE, BRADYCARDIA, HYPERTENSION AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE PRODUCT. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. BASED ON AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, HOWEVER, THERE WAS NO INDICATION OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE. AS PART OF MANUFACTURING QUALITY PROCESS, ALL CATHETERS ARE INSPECTED DURING THE FINAL INSPECTION TO ENSURE THE DEVICE STRUCTURE AND INTEGRITY. IN ADDITION, SAMPLES FROM EACH LOT ARE VISUALLY, DIMENSIONALLY AND FUNCTIONALLY INSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT SIX DAYS POST SUCCESSFUL RX ACCULINK STENT IMPLANTATION IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT WAS FOUND UNRESPONSIVE ON THE FLOOR AT HOME AND WAS HOSPITALIZED FOR A STROKE WITH LEFT HEMIPARESIS, ABDOMINAL AND BACK DISCOMFORT, LEUKOCYTOSIS, RHABDOMYOLYSIS AND HYPOTENSION. CT SCAN OF THE HEAD REVEALED SUBACUTE INFARCTS INVOLVING THE RIGHT FRONTAL LOBE, RIGHT AND OCCIPITAL LOBES, AND LEFT CEREBELLUM SUGGESTIVE OF CARDIOEMBOLIC PHENOMENON. THE CAROTID STENT WAS PATENT. CT OF THE ABDOMEN SHOWED A PRE-EXISTING ABDOMINAL AORTIC ANEURYSM WITH AIR IN THE WALL OF THE ANEURYSM SUGGESTING AORTODUODENAL FISTULA. ANTIBIOTICS WERE GIVEN FOR CLOSTRIDIUM PERFRINGENS SEPTICEMIA. FOLLOW-UP CT ANGIOGRAM SHOWED INCREASE IN SIZE OF ANEURYSM AND RETROPERITONEAL GAS. PALLIATIVE CARE WAS GIVEN AND THE PATIENT DIED 12 DAYS POST PROCEDURE, ON (B)(6)2010. THE CAUSE OF DEATH WAS AORTIC ANEURYSM RUPTURE. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9112351

    Patients

    Seq Age Sex Outcome Treatment
    1 Death EMBOLIC PROTECTION: EMBOSHIELD NAV 6| OTHER: BIVARLIRUDIN