BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2123243 · Received June 14, 2011

    Report

    Report Number
    2024168-2011-04167
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT AND ITS PACKAGING WERE NOT RETURNED; THEREFORE, THE EXPIRATION DATE ON THE SPECIFIC PRODUCT LABELS COULD NOT BE CONFIRMED. HOWEVER, A REVIEW OF THE LABELS ATTACHED TO THE LOT HISTORY RECORD FOR THIS LOT WAS CONDUCTED AND ALL LABELS INDICATED AN EXPIRATION DATE (USE BY DATE) OF 3/31/2011, WHICH IS APPROXIMATELY 36 MONTHS FROM THE DATE OF MANUFACTURE (4/2008), AS SPECIFIED IN THE PRODUCT SPECIFICATION. THIS CONFIRMS THAT THE PRODUCT WAS LABELED CORRECTLY, AND BASED ON THE REPORTED INFORMATION THE PRODUCT WAS USED 4 DAYS PAST THE LABELED EXPIRATION DATE. IT SHOULD BE NOTED THAT THE VISION INSTRUCTIONS FOR USE STATES: NOTE THE PRODUCT USE BY DATE SPECIFIED ON THE PACKAGE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ENTERED THE EMERGENCY ROOM IN THE HOSPITAL WITH AN ARRHYTHMIA WHICH LED TO CARDIAC ARREST. THE SYMPTOMS WERE REVERSED IN THE EMERGENCY ROOM AND THE PATIENT WAS INTUBATED AND CONNECTED TO A MECHANICAL VENTILATOR PRIOR TO UNDERGOING ANGIOPLASTY. THE PATIENT WAS THEN IMPLANTED WITH 3 BARE METAL STENTS IN THE LEFT ANTERIOR DESCENDING ARTERY, WHICH INCLUDED THE 2.25 X 23 MM MULTI-LINK VISION, AND A 2.75 X 18 MM MULTI-LINK VISION IN THE CIRCUMFLEX ARTERY. POST-PROCEDURE IT WAS DISCOVERED THAT THE 2.25 X 23 MM MULTI-LINK VISION WAS USED AFTER THE EXPIRATION DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 8040731

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR STENT: PRESILIUM 2.75X24, 2.75X17, VISION 2.75X18