BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 3942420 · Received July 17, 2014

    Report

    Report Number
    2024168-2014-04599
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON THE ANALYSIS OF THE 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. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR FAILURE TO ADVANCE REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE CORONARY STENT GRAFT SYSTEM, GRAFTMASTER RX INSTRUCTIONS FOR USE (IFU) STATES: IF MORE THAN ONE STENT GRAFT IS REQUIRED, THE DISTAL STENT GRAFT SHOULD BE PLACED INITIALLY, FOLLOWED BY PLACEMENT OF THE PROXIMAL STENT GRAFT. STENT GRAFT PLACEMENT IN THIS ORDER OBVIATES THE NEED TO CROSS THE PROXIMAL STENT GRAFT WHEN PLACING THE DISTAL STENT GRAFT, AND REDUCES THE CHANCES FOR DISLODGING THE PROXIMAL STENT GRAFT

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: STENT: 2.8X16MM GRAFTMASTER; 4.0X16MM GRAFTMASTER. (B)(4). THE 4.0X16MM RX GRAFTMASTER STENT MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LONG PERFORATION CAUSED BY A NON-ABBOTT DEVICE IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 4.0X16MM GRAFTMASTER STENT AND THE 2.8X16MM GRAFTMASTER STENT WERE SUCCESSFULLY DEPLOYED IN THE PROXIMAL PORTION OF THE PERFORATION. A 2.8X26MM GRAFTMASTER STENT DELIVERY SYSTEM (SDS) AND A 4.0X16MM GRAFTMASTER SDS WERE UNABLE TO CROSS DISTALLY DUE TO INTERACTIONS WITH PROXIMALLY DEPLOYED 4.0X16MM AND 2.8X16MM GRAFTMASTER STENTS. REPORTEDLY, THERE WAS NO DAMAGE TO THE DEPLOYED 4.0X16MM AND 2.8X16MM GRAFTMASTER STENTS. THE PATIENT WAS TRANSFERRED TO SURGERY TO SEAL THE PERFORATION, CAUSING A DELAY IN TREATMENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419158 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 3110641

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R