BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 1945115 · Received January 3, 2011

    Report

    Report Number
    2024168-2011-00007
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 7, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD IN THE BALLOON AND INFLATION LUMEN, WHICH IS CONSISTENT WITH A LEAK WHILE IN THE PATIENT ANATOMY. THE PROXIMAL END OF THE BALLOON WAS WRINKLED AND THE SHAFT WAS WRINKLED 4.5CM DISTAL TO THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 1CM. AN ATTEMPT WAS MADE TO PRESSURIZE THE STENT DELIVERY SYSTEM (SDS) WHEN FLUID LEAKED OUT OF A TEAR IN THE SHAFT AT THE WRINKLED SECTION. THE PATIENT ANATOMY WAS HEAVILY TORTUOUS AND MILDLY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE SHAFT COULD HAVE WRINKLED DURING ADVANCEMENT IN THE CALCIFIED LESION, RESULTING IN THE SHAFT AND BALLOON WRINKLING AND SUBSEQUENTLY TEARING THE SHAFT. THE REPORTED EVENT IS AN EXPECTED OCCURENCE WITH MINIMAL TO NO PATIENT IMPACT PER THE DEVICE RISK ASSESSMENT AND THERE IS NO EVIDENCE TO SUGGEST A POTENTIAL PRODUCT DEFICIENCY. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET VESSEL IN THE LEFT ANTERIOR DESCENDING ARTERY WAS VERY TORTUOUS AND THE INITIAL GUIDE WIRE INTRODUCTION WAS DIFFICULT. PRE-DILATATION WAS PERFORMED PRIOR TO ATTEMPTS TO CROSS THE LESION WITH THE STENT DELIVERY SYSTEM (SDS). DURING THE PROCESS THE LUMEN FILLED WITH BLOOD SIGNALING A BREACH OF THE SDS. THE LESION WAS TREATED WITH 2 OTHER NON-ABBOTT STENTS. PATIENT INFORMATION WILL NOT BE PROVIDED DUE TO CONFIDENTIALITY REQUIREMENTS. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0012661

    Patients

    Seq Age Sex Outcome Treatment
    1