BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2800501 · Received October 22, 2012

    Report

    Report Number
    2024168-2012-06669
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 27, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL GRAFTMASTER REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    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. 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 PATIENT HAD A LARGE ANEURYSM LOCATED IN THE SAPHENOUS VEIN GRAFT TO THE RIGHT CORONARY ARTERY (RCA). ANGIOGRAPHY CONFIRMED A VERY LARGE ANEURYSM WITH IN AND OUT FLOW THROUGH THE ANEURYSM. THE 4.0 X 16 MM GRAFTMASTER STENT WAS IMPLANTED. FLOW WAS REDUCED INTO THE ANEURYSM, BUT STILL PRESENT, AS THE ANEURYSM WAS NOT COMPLETELY EXCLUDED. BALLOONING WAS PERFORMED WITH AN UNSPECIFIED 5.0 BALLOON, HOWEVER, FLOW WAS STILL GOING INTO THE ANEURYSM. IT WAS FELT THAT THE FLOW WAS COMING IN A RETROGRADE MANNER ALONG THE DISTAL PORTION OF THE STENT, DUE TO A MISMATCH IN SIZE OF THE STENT TO THE VEIN GRAFT. THEREFORE, A SECOND GRAFTMASTER STENT WAS THEN IMPLANTED IN AN OVERLAPPING MANNER AND EXPANDED INTO A MORE DISTAL PORTION OF THE VEIN GRAFT, WHICH WAS SMALLER IN CALIBER. THERE WAS STILL A SMALL AMOUNT OF FLOW THROUGH THE STENTS INTO THE ANEURYSM, SO AN UNSPECIFIED 5.5 X 15 MM BALLOON WAS USED WITH INFLATIONS OF 2 TO 2.5 MINUTES. POST BALLOON INFLATION, NO FLOW INTO THE ANEURYSM WAS NOTED AND THE ANEURYSM WAS FELT TO BE EXCLUDED. NO ADVERSE PATIENT SEQUELA WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 622814

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention