BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 3812879 · Received May 15, 2014

    Report

    Report Number
    2024168-2014-03067
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 20, 2014
    Report Date
    April 21, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: SION BLUE; GUIDE CATHETER: TAIGA 6F JL3.5. (B)(4) - FAILURE TO FOLLOW STEPS/INSTRUCTIONS. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS AN ACUTE MYOCARDIAL INFARCTION CASE AND THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD TORTUOSITY AND 100% STENOSIS. THE VESSEL DIAMETER WAS 2.5-3.0 MM AND THE LESION LENGTH WAS 30 MM. AFTER PRE-DILATATION WAS PERFORMED WITH A 2.0X15 MM NON-ABBOTT DILATATION CATHETER, A 2.25X12 MM RX MULTI-LINK 8 CORONARY STENT SYSTEM WAS ADVANCED TO THE TARGET LESION AND THOUGHT TO BE IMPLANTED. HOWEVER, IT WAS CONFIRMED THAT THE STENT WAS NOT IMPLANTED IN THE LESION WITH AN INTRAVASCULAR ULTRASOUND (IVUS). REPORTEDLY, THE PHYSICIAN SEARCHED THE PATIENT ANATOMY AND INSIDE OF THE GUIDING CATHETER FOR THE DISLODGED STENT BUT THE STENT WAS FOUND INSIDE OF THE PROTECTIVE SHEATH. REPORTEDLY, THE MANDREL AND PROTECTIVE SHEATH WERE REMOVED TOGETHER. THE PROCEDURE WAS CONTINUED USING A NEW SAME SIZE MULTI-LINK 8 CORONARY STENT SYSTEM AND A 3.0X23 MULTI-LINK 8 STENT WAS IMPLANTED TO SUCCESSFULLY TREAT THE TARGET LESION. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUE AFTER PERFORMING POST-IVUS. 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
    290743 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2083141

    Patients

    Seq Age Sex Outcome Treatment
    1