BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2801893 · Received October 23, 2012

    Report

    Report Number
    2024168-2012-06690
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 3, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE PREMATURE DEPLOYMENT WAS ABLE TO BE CONFIRMED. THE RESISTANCE WITH THE SHEATH COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF THE ACCULINK DEVICE INTO A 7 FRENCH NON-ABBOTT SHEATH, SLIGHT RESISTANCE WAS ENCOUNTERED AND 3 MM OF STENT STRUTS BECAME EXPOSED DESPITE THE HANDLE BEING LOCKED. THE ACCULINK WAS EXCHANGED FOR AN XACT 7-9 X 40 MM STENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS 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 1051161

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH: COOK 7F SHUTTLE SHEATH