BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 4935904 · Received July 23, 2015

    Report

    Report Number
    2024168-2015-04104
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    June 24, 2015
    Report Date
    July 1, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE DEVICE IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER 2.8 X 16MM GRAFTMASTER REFERENCED IN B5 IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IT HAS BEEN DETERMINED THAT THE REPORTED FAILURE TO ADVANCE AND THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE RIGHT CORONARY ARTERY, A PERFORATION OCCURRED WHICH REQUIRED THE USE OF A GRAFTMASTER STENT. A 2.8 X 16 MM GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT FAILED TO CROSS TO THE PERFORATION DUE TO THE ANATOMY. A SECOND 2.8 X 16 MM GRAFTMASTER SDS WAS ADVANCED, BUT ALSO DIDN'T CROSS DUE TO THE ANATOMY. THE PERFORATION WAS SUCCESSFULLY SEALED WITH PROLONGED BALLOON INFLATIONS, AND THE PATIENT HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479043 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 4082541

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention