BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2024371 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01849
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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. 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. THROUGHOUT THE MANUFACTURING PROCESS, ALL STENT DELIVERY SYSTEMS ARE 100% 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. 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. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN 2 INCIDENTS REPORTED FOR FAILURE TO ADVANCE FOR THIS LOT. HOWEVER, AS MENTIONED ABOVE, THE INABILITY TO CROSS A LESION IS OFTEN RELATED TO CIRCUMSTANCES OF THE PROCEDURE OR CHARACTERISTICS OF THE LESION AND IS NOT GENERALLY A REFLECTION OF A QUALITY DEFICIENCY WITH THE PRODUCT. THUS, IN REVIEW OF ALL INCIDENTS, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. 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 A PERFORATION OCCURRED DURING THE USE OF A NON-ABBOTT DEVICE. THE GRAFTMASTER COULD NOT CROSS THE CALCIUM TO TREAT THE PERFORATION. THE PERFORATION WAS TREATED USING ANOTHER STENT [NON-SPECIFIED]. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 588163

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention