BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3180695 · Received June 20, 2013

    Report

    Report Number
    2024168-2013-03837
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED FAILURE TO CROSS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE MATERIAL AT THE GUIDE WIRE EXIT NOTCH SLIGHTLY LIFTED AND THE NOTCH WAS TORN FOR A LENGTH OF 1MM. THE NOTED NOTCH DAMAGE WAS NOT REPORTED AND MOST LIKELY RESULTED FROM POST PROCEDURE HANDLING SUCH THAT THE GUIDE WIRE PROTRUDED THOUGH THE GUIDE WIRE EXIT NOTCH AND RESULTED IN THE NOTED TEAR. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS 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 PROCEDURE WAS TO TREAT AN ANEURYSM LOCATED IN THE HEAVILY TORTUOUS, MID RIGHT CORONARY ARTERY. THE 3.0X16 MM GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE LESION. THE DECISION WAS MADE TO STOP THE PROCEDURE WITHOUT FURTHER TREATMENT AS THERE WAS NO ACTIVE BLEEDING. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE ANALYSIS REVEALED A TEAR IN THE SHAFT OF THE DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279899 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 728479

    Patients

    Seq Age Sex Outcome Treatment
    1