BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2060220 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02658
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    April 2, 2009
    Report Date
    March 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THE JOSTENT GRAFTMASTER 3.0 X 12 IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. FAILURE TO ADVANCE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY (TORTUOSITY OR CALCIFICATION), PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION, ACCESSORY DEVICE SUPPORT, OR INTERACTION WITH ACCESSORY DEVICES OR PREVIOUSLY DEPLOYED DEVICES. THROUGHOUT THE MANUFACTURING PROCESS, ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED FOR CATHETER AND STENT DAMAGE. ALTHOUGH THE ANATOMICAL CONDITIONS WERE NOT REPORTED, FAILURE TO ADVANCE IS NOT OFTEN ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND IS LIKELY RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE DEVICE HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED AND THE LOT NUMBER WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT THE RIGHT CORONARY ARTERY, A PERFORATION OCCURRED DURING USE OF A NON-ABBOTT ATHERECTOMY DEVICE. A 3.0 AND 3.5 BALLOON WERE USED TO TAMPANADE THE VESSEL. AT THIS TIME THE PATIENT WAS HEMODYNAMICALLY STABLE, WITH BLOOD PRESSURE MAINTAINED. PROTAMINE WAS GIVEN TO FLUSH THE HEPARIN. A 3.0 X 19 GRAFTMASTER WAS ATTEMPTED TO TREAT THE PERFORATION; HOWEVER, EVEN WITH A BUDDY WIRE SYSTEM, THE DEVICE WOULD NOT CROSS. A 3.0 X 12 GRAFTMASTER WAS THEN ATTEMPTED TO BE ADVANCED, BUT IT WOULD NOT CROSS THE LESION. DURING REMOVAL, THE STENT DISLODGED FROM THE BALLOON, AND WAS CONFIRMED TO BE IN THE MID RCA. IT WAS DECIDED THAT THE PATIENT WOULD BE SENT FOR CORONARY ARTERY BY-PASS SURGERY FOR DRAINAGE OF THE PERICARDIAL SAC. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM IN STABLE CONDITION. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention GUIDE CATH: 6F JR 4.0