BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2843050 · Received November 21, 2012

    Report

    Report Number
    2024168-2012-07411
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. (B)(6). THE STENT REMAINS IN THE VESSEL; IT IS INDICATED THAT THE STENT DELIVERY SYSTEM 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. THE ADDITIONAL 3 GRAFTMASTERS ARE BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFTMASTER STENT WAS USED TO TREAT A PERFORATION THAT OCCURRED IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT CORONARY ARTERY (RCA) WITH THE USE OF A NON-ABBOTT DEVICE. IT WAS NOTED THAT FOUR GRAFTMASTER STENTS WERE PLACED IN AN OVERLAPPING FASHION [3.0 X 19 MM, 3.5 X 16 MM, 4.0 X 19 MM, 3.0 X 12 MM] WITH A SMALL LEAK REMAINING AT THE PROXIMAL AND DISTAL ENDS REQUIRING SURGICAL TREATMENT. ALTHOUGH THE STENTS MINIMIZED THE PERFORATION LEAK, IT CONTINUED TO LEAK AT THE PROXIMAL AND DISTAL ENDS/AREA OF THE STENTS AND AFTER ABOUT 2 HOURS THE PATIENT WAS TRANSFERRED FOR SURGICAL TREATMENT WITH A SUCCESSFUL OUTCOME. THERE APPEARED TO BE A WISP OF CONTRACT INTO THE PERICARDIAL SPACE AND THE VALVE DID NOT APPEAR TO BE WORKING AS THE CHAMBER BECAME FILLED FROM THE LEAK. THERE WAS NO TAMPONADE PERFORMED. A 40 CC INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED, BUT NO CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED OR NEEDED. THROUGHOUT THE PROCEDURE THE PATIENT REMAINED ALERT AND ORIENTED. POST STENT PLACEMENT THE PATIENT COMPLAINED OF NECK PAIN AS 9 OUT OF 10 PRIOR TO TRANSFER FOR SURGICAL TREATMENT. THE PATIENT WAS REPORTED AS DOING FINE POST SURGERY. 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 726926

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R STENT: MEDTRONIC