BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3092611 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02771
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 25, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THE LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 3.0X19 MM GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS BEING USED IN AN ATTEMPT TO TREAT A PERFORATION THAT OCCURRED DURING USE OF ANOTHER DEVICE IN THE RIGHT CORONARY ARTERY. THE GRAFTMASTER SDS FAILED TO CROSS THE LESION FOR TREATMENT. TWO BARE METAL STENTS WERE USED TO TREAT THE PERFORATION SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE FAILURE OF THE SDS TO CROSS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193936 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 710309

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention