BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1980756 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00735
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    September 29, 2010
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO ADVANCE/PHYSICAL RESISTANCE 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. THROUGHOUT THE MANUFACTURING PROCESS, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR CATHETER AND STENT DAMAGE. THE PATIENT ANATOMY WAS MODERATELY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. BASED ON THE INFORMATION PROVIDED, THE REPORTED INABILITY TO ADVANCE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE JOSTENT GRAFTMASTER FAILED TO CROSS TO TREAT A PERFORATION CAUSED BY AN UNKNOWN DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE JOSTENT GRAFTMASTER FAILED TO CROSS TO TREAT A PERFORATION CAUSED BY AN UNKNOWN DEVICE. THE PERFORATION, WHICH WAS LOCATED IN THE RIGHT CORONARY ARTERY, WAS DESCRIBED AS MODERATELY CALCIFIED AND WAS ULTIMATELY TREATED WITH SEVERAL PROLONGED BALLOON INFLATIONS. THE PATIENT WAS FINE POST PROCEDURE. 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 627929

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention