BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK 8

    MDR report key: 3939331 · Received July 16, 2014

    Report

    Report Number
    2024168-2014-04564
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION, XTR. GUIDE CATH: HYPERION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. DISSECTION IS LISTED IN THE MULTI-LINK 8 INSTRUCTION FOR USE (IFU) AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, CONCENTRIC, MILDLY CALCIFIED AND 90% STENOSED DISTAL CIRCUMFLEX ARTERY. THE PATIENT WAS ADMITTED WITH AN ACUTE MYOCARDIAL INFARCTION (AMI). AFTER A NON-ABBOTT GUIDE WIRE CROSSED THE LESION, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED. A 2.5 X 18 MM MULTI-LINK 8 WAS ADVANCED TO THE LESION AND INFLATED TO 6 ATMOSPHERES WHEN THE BALLOON RUPTURED AND A DISSECTION OCCURRED. THE 2.5 X 18 MM MULTI-LINK 8 DID NOT COVER THE ENTIRE LESION SO A 2.5 X 12 MM MULTI-LINK 8 WAS IMPLANTED TO COVER THE REST OF THE LESION, TREAT THE DISSECTION AND COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415101 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2070641

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention