BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2090256 · Received May 16, 2011

    Report

    Report Number
    2024168-2011-03492
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. IN THIS CASE, NO PATIENT ANATOMICAL INFORMATION WAS PROVIDED, WHICH MAY HAVE AIDED THE INVESTIGATION. HOWEVER, 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. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. 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 OTHER GRAFTMASTER, AND THE 2.0 X 12MM MINI VISION ARE EACH BEING FILED UNDER SEPARATE MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFTMASTER DEVICES WERE BEING USED TO TREAT A PERFORATION THAT OCCURRED DURING POST DEPLOYMENT OF A 2.0 X 12 MM MINI VISION STENT WITH A 2.0 X 12 MM VOYAGER BALLOON; HOWEVER, THE GRAFTMASTERS WERE 3.0 DIAMETER STENTS AND WOULD NOT CROSS INTO THE STENT TO TREAT THE PERFORATION. ON FLUOROSCOPY THE SEPTAL PERFORATION APPEARED TO HAVE SEALED ITSELF, WITH NO FURTHER INTERVENTION REQUIRED. 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 640915

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR STENT: 2.0 X 12MM MINI VISION