BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 3222636 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04327
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. BASED ON VISUAL 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. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INVESTIGATION, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATING: IT IS THE PHYSICIAN'S OPINION THE STENT WAS ATTACHED TO THE PROTECTIVE SHEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF A MULTI LINK 8 STENT DELIVERY SYSTEM (SDS), OUTSIDE OF THE PATIENTS ANATOMY, AT THE MOMENT OF REMOVING THE YELLOW PROTECTIVE SHEATH, THE STENT CAME OFF AND FELL ON THE TABLE. REPORTEDLY, THERE WAS NO RESISTANCE ENCOUNTERED DURING REMOVAL OF THE PROTECTIVE SHEATH. THE MULTI LINK 8 SDS WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321529 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2082941

    Patients

    Seq Age Sex Outcome Treatment
    1