BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2840797 · Received November 20, 2012

    Report

    Report Number
    2024168-2012-07336
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 29, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 DURING A PROCEDURE TO TREAT A LESION IN THE OBTUSE MARGINAL (OM), A PERFORATION OCCURRED WHICH REQUIRED THE USE OF A GRAFTMASTER STENT. THE 3.5 X 16 MM GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT AFTER MULTIPLE ATTEMPTS, THE SDS COULD NOT CROSS TO THE PERFORATION IN THE BIFURCATION AREA OF THE OM AND THE CIRCUMFLEX ARTERIES. LONG BALLOON INFLATIONS WERE USED TO SEAL THE PERFORATION SUCCESSFULLY. THE PATIENT HAD A EXCELLENT OUTCOME. 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 699396

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention