BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2090255 · Received May 16, 2011

    Report

    Report Number
    2024168-2011-03493
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF PERFORATION, AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PERFORATION AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE TWO GRAFTMASTERS ARE EACH BEING FILED UNDER SEPARATE MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFTMASTER DEVICES WERE BEING USED TO TREAT A PERFORATION THAT OCCURRED DURING POST DEPLOYMENT OF A 2.0 X 12 MM MINI VISION STENT WITH A 2.0 X 12 MM VOYAGER BALLOON; HOWEVER, THE GRAFTMASTERS WERE 3.0 DIAMETER STENTS AND WOULD NOT CROSS INTO THE STENT TO TREAT THE PERFORATION. ON FLUOROSCOPY THE SEPTAL PERFORATION APPEARED TO HAVE SEALED ITSELF, WITH NO FURTHER INTERVENTION REQUIRED. THE PATIENT IS REPORTED TO BE WELL. 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 1020741

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention