BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1964312 · Received January 19, 2011

    Report

    Report Number
    2024168-2011-00381
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. SINCE THE GRAFTMASTER STENT REMAINS IN THE PATIENT AND THE SDS WAS NOT RETURNED FOR EVALUATION, IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE DEVICE, WHICH MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE REPORTED DIFFICULTIES. HOWEVER, THERE WAS NO NOTE OF ANY DAMAGE OBSERVED TO THE STENT DELIVERY SYSTEM (SDS) OR STENT IMPLANT PRIOR TO THE PROCEDURE, SUGGESTING THAT A PRODUCT DEFICIENCY LIKELY DID NOT CONTRIBUTE TO THE DIFFICULTY EXPERIENCED. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, DAMAGE TO THE SDS OR THE STENT IMPLANT, INTERACTIONS WITH OTHER DEVICES, AND ACCESSORY DEVICE SUPPORT. ALTHOUGH NO PATIENT ANATOMICAL INFORMATION WAS PROVIDED, THE FAILURE TO ADVANCE IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND WAS LIKELY RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE FINISHED PRODUCT DEVICE HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL MANUFACTURING DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR CATHETER DAMAGE, STENT DAMAGE AND PROPER STENT PLACEMENT. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY PROPER GUIDING CATHETER AND GUIDE WIRE MOVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFTMASTER STENT WAS BEING USED TO TREAT A PERFORATION CAUSED BY A NON-ABBOTT DEVICE. THE GRAFTMASTER WAS DIFFICULT TO NEGOTIATE THROUGH THE VESSEL BECAUSE OF A PREVIOUSLY IMPLANTED STENT, RESULTING IN THE DECISION TO IMPLANT THE GRAFTMASTER AT THE PROXIMAL END OF THE PERFORATION. THE PERFORATION WAS TREATED SUCCESSFULLY WITH MULTIPLE BALLOON INFLATIONS. THE PATIENT IS REPORTED TO BE WELL. 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 643749

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention