BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 2955801 · Received February 11, 2013

    Report

    Report Number
    2024168-2013-00795
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED FAILURE TO CROSS AND RESISTANCE WITH THE ANATOMY COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE REPORTED BULKY PROFILE WAS NOT CONFIRMED. BASED ON VISUAL AND DIMENSIONAL ANALYSIS 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. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    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 INVESTIGATION. 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 A PROCEDURE TO TREAT A DIFFUSED LESION IN THE MID DIAGONAL ARTERY WITH MILD CALCIFICATION, A 3.0X33 RX MULTI-LINK 8 (ML8) STENT SYSTEM WAS ADVANCED BUT COULD NOT CROSS THE LESION. THE 3.0X33 RX ML8 STENT SYSTEM WAS WITHDRAWN FROM THE PATIENT ANATOMY WITH SLIGHT RESISTANCE AND A 3.0X33 NON-ABBOTT STENT WAS ADVANCED SUCCESSFULLY. REPORTEDLY, THE PHYSICIAN FELT THE ML8 STENT WAS MORE BULKY IN CRIMPED STATUS AND MUCH HARDER TO CROSS THE LESION COMPARED TO THE NON-ABBOTT STENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59832 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2030241

    Patients

    Seq Age Sex Outcome Treatment
    1