BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2023924 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01821
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 21, 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. ALTHOUGH THE GRAFTMASTER WAS NOT RETURNED FOR ANALYSIS AND MAY HAVE AIDED THE INVESTIGATION, THERE WAS NO NOTE OF ANY DAMAGE OBSERVED TO THE STENT DELIVERY SYSTEM (SDS) OR STENT IMPLANT PRIOR TO THE PROCEDURE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED COMPLAINT. 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, OR ACCESSORY DEVICE SUPPORT. AN INTERACTION WITH THE MILDLY CALCIFIED LESION AND/OR THE PREVIOUSLY IMPLANTED GRAFTMASTER LIKELY CONTRIBUTED TO THE DIFFICULTY CROSSING. OVERALL, THE FAILURE TO ADVANCE IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND APPEARS TO BE 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. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS ISSUE WITH THIS LOT. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, 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. THE 3.5 X 19 MM GRAFTMASTER IS BEING FILED UNDER A SEPARATE MFR NUMBER. THE 4.0 X 8 MM VOYAGER IS ALSO BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERFORATION OCCURRED IN PROXIMAL RIGHT CORONARY ARTERY DURING USE OF A VOYAGER NC BALLOON FOR PREDILATATION THAT REQUIRED TREATMENT WITH A GRAFTMASTER STENT. THE 3.5 X 19 MM GRAFTMASTER USED WOULD NOT CROSS AND DURING THE ATTEMPT TO REMOVE THE STENT DELIVERY SYSTEM (SDS) INTO THE GUIDING CATHETER RESISTANCE WAS FELT AND THE STENT IMPLANT DISLODGED FROM THE BALLOON INTO THE CORONARY. A BALLOON CATHETER WAS USED TO CAPTURE AND PLACE THE STENT AT THE PROXIMAL END OF THE PERFORATION, WHERE IT WAS DEPLOYED SUCCESSFULLY. A 3.5 X 12 MM GRAFTMASTER WAS SELECTED TO TREAT THE DISTAL END OF THE PERFORATION; HOWEVER, THIS FAILED TO CROSS THROUGH THE ALREADY DEPLOYED GRAFTMASTER STENT AND WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. A 3.5X18 MM BARE METAL STENT WAS USED TO TREAT THE DISTAL END OF THE PERFORATION SUCCESSFULLY. 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 618548

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention STENT: 3.5 X 19 MM GRAFTMASTER