BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1980438 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00724
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. ALTHOUGH THE MINI VISION STENT DELIVERY SYSTEM(SDS) WAS NOT RETURNED FOR ANALYSIS, THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE DEVICE PRIOR TO USE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED. THE INABILITY TO CROSS THE LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, DAMAGE TO THE SDS OR THE STENT IMPLANT, INTERACTIONS WITH OTHER DEVICES AND/OR ACCESSORY DEVICE SUPPORT. NO PATIENT ANATOMICAL INFORMATION WAS PROVIDED, WHICH MAY HAVE AIDED THE INVESTIGATION. HOWEVER, THE FAILURE TO ADVANCE IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND WAS LIKELY RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE PATIENT EFFECT OF DISSECTION, AS LISTED IN THE MINI VISION INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. DISSECTIONS CAN BE INFLUENCED BY SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE REPORTED RESISTANCE WITHIN THE LESION APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED DISSECTION AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2.0 X 08 MM MINI VISION WAS UNABLE TO CROSS THE RIGHT CORONARY ARTERY (RCA). THERE MAY HAVE BEEN A DISSECTION AFTER THIS FAILURE TO CROSS; THEREFORE, A LONGER, 2.0 X 28 MM MINI VISION WAS INSERTED, BUT WAS ALSO UNABLE TO CROSS THE RCA. A SECOND 2.0 X 28 MM MINI VISION WAS ABLE TO CROSS AND WAS IMPLANTED TO TREAT THE POSSIBLE DISSECTION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THERE WAS NO ADDITIONAL INFORMATION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention