BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1478954 · Received September 21, 2009

    Report

    Report Number
    3004742046-2009-00243
    Event Type
    Injury
    Date Received
    September 21, 2009
    Date of Event
    August 26, 2009
    Report Date
    September 1, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE #1, THE RX ACCUNET EMBOLIC PROTECTION DEVICE LOT NUMBER 8021851 IS BEING FILED UNDER MANUFACTURER REPORT NUMBER 3004742046-2009-00242. EVALUATION SUMMARY: THE DEVICE WAS NOT RETURNED. IT IS POSSIBLE THAT THE INACCURATE DELIVERY OF THE STENT MAY BE THE RESULT OF, BUT NOT LIMITED TO, THE VESSEL MORPHOLOGY, THE VESSEL DIAMETER WHICH COULD HAVE BEEN LARGER THAN THE STENT, THE STENT NOT APPOSING THE VESSEL WALL WHEN FULLY DEPLOYED AND/OR INADVERTENT MOVEMENT OF THE HANDLE DURING DEPLOYMENT. FURTHERMORE, AS PER THE RX ACCULINK INSTRUCTIONS FOR USE, SECTION 5.2 STENT PLACEMENT- PRECAUTIONS: "PRIOR TO STENT DEPLOYMENT, REMOVE ALL SLACK FROM THE DELIVERY SYSTEM." BASED ON AVAILABLE INFORMATION, THE HEAVILY TORTUOUS VESSEL COULD HAVE CONTRIBUTED TO THE EVENT. AS PART OF MANUFACTURING QUALITY PROCESS, ALL CATHETERS ARE INSPECTED DURING THE FINAL INSPECTION TO ENSURE THE PRODUCT STRUCTURE AND INTEGRITY. IN ADDITION, SAMPLES FROM EACH LOT ARE VISUALLY, DIMENSIONALLY AND FUNCTIONALLY INSPECTED. HYPOTENSION IS A KNOWN POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE, AS LISTED IN THE INSTRUCTIONS FOR USE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY DID NOT REVEAL ANY NON-CONFORMITIES, WHICH COULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    DEVICE #2 MALFUNCTION: INACCURATE DELIVERY. SYMPTOMS/AE: PLACEMENT OF A SECOND STENT. TIME OF MALFUNCTION/AE: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, PLACEMENT OF THE RX ACCUNET WAS DIFFICULT DUE TO THE VESSEL TORTUOSITY. THE BUDDY WIRE TECHNIQUE WAS USED AND THE DEVICE WAS SUCCESSFULLY PLACED. WHILE DEPLOYING THE RX ACCULINK STENT, THE STENT MOVED UPWARD, NOT FULLY COVERING THE TARGET LESION. AN XACT STENT WAS PLACED COVERING THE PROXIMAL LESION; HOWEVER, DURING DEPLOYMENT OF THE XACT STENT, THE PATIENT HAD A SHORT EPISODE OF HYPOTENSION TREATED WITH A BOLUS OF NEOSYNEPHRINE AND EXPERIENCED A STROKE DISPLAYING APHASIA AND FLACCIDITY OF THE RIGHT SIDE. TWO DAYS POST PROCEDURE, AN MRI SHOWED EIGHT SMALL AREAS OF EMBOLIC INFARCTS IN THE BILATERAL FRONTAL, LEFT PARIETAL PRECENTRAL GYRI. THE PATIENT STARTED IMPROVING ALMOST IMMEDIATELY AND FIVE DAYS POST PROCEDURE WAS BACK TO BASELINE AND DISCHARGED TO HOME. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9011551

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention MS SHEATH| (DEVICE #1) RX ACCUNET EMBOLIC PROTECTION DEVICE| LOT #8021851| AVANTI| 6F BENTSON HANAFEE WILSON CATHETER| BIVALIRUDIN| STABILIZER XS GUIDEWIRE| 5X20X135| VIATRAC 4X20X135