BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1952605 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00087
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 14, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. STENT: 3.0 X 12 MM GRAFTMASTER ((B)(4)), 3.0 X 18 MM RX VISION ((B)(4)). FAILURE TO ADVANCE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT 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. 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. THROUGHOUT THE MANUFACTURING PROCESS, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR CATHETER AND STENT DAMAGE. THE 3.0 X 12 MM GRAFTMASTER ((B)(4)), AND THE 3.0 X 18 MM RX VISION ((B)(4)), ARE EACH BEING FILED UNDER SEPARATE MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEPLOYMENT OF AN RX VISION STENT IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD), A LONG PERFORATION OCCURRED. AN ATTEMPT WAS MADE TO TREAT THE PERFORATION WITH A 3.0 X 12 MM GRAFTMASTER STENT; HOWEVER, IT WOULD NOT CROSS AND DURING REMOVAL OF THE DEVICE THE STENT DISLODGED FROM THE BALLOON AT THE PROXIMAL END OF THE PERFORATION AND WAS DEPLOYED SUCCESSFULLY. A 3.5 X 19 MM GRAFTMASTER WAS USED IN AN ATTEMPT TO CROSS TO TREAT THE DISTAL END OF THE PERFORATION; HOWEVER, IT ALSO WOULD NOT CROSS. THE REMAINING UNTREATED PART OF THE PERFORATION WAS SUCCESSFULLY TREATED WITH PROLONGED BALLOON INFLATIONS. THE PATIENT IS REPORTED TO BE STABLE. 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 58 YR Required Intervention