BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2103712 · Received May 26, 2011

    Report

    Report Number
    2024168-2011-03726
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 STENT DELIVERY SYSTEM (SDS) OR THE STENT IMPLANT, INTERACTIONS WITH OTHER DEVICES, OR ACCESSORY DEVICE SUPPORT. ALTHOUGH THE GRAFTMASTER WAS NOT RETURNED FOR ANALYSIS AND MAY HAVE AIDED THE INVESTIGATION, THERE WAS NO NOTE OF ANY DAMAGE OBSERVED TO THE SDS OR STENT IMPLANT PRIOR TO THE PROCEDURE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED COMPLAINT. 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. DUE TO THE INHERENTLY SERIOUS AND EMERGENT USE OF THE GRAFTMASTER DEVICE, THE PERFORATION ITSELF AND/OR THE FAILURE TO TREAT THE PERFORATION MAY HAVE POSSIBLY RESULTED IN THE REPORTED HEMORRHAGE. A REVIEW OF THE FINISHED PRODUCT DEVICE HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. FURTHERMORE, A QUERY OF THE COMPLAINT HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR FAILURE TO ADVANCE 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 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.

    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. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE SECOND GRAFTMASTER, IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DEPLOYMENT OF A NON-ABBOTT BARE METAL STENT, A PERFORATION WAS NOTED. A 4.0 X 26 MM GRAFTMASTER WAS SELECTED FOR TREATMENT; HOWEVER, IT WOULD NOT CROSS. A 4.0 X 16 MM GRAFTMASTER WAS SELECTED AND IT TO WOULD NOT CROSS. ANOTHER NON-ABBOTT BARE METAL STENT WAS DEPLOYED AND BALLOONING WAS PERFORMED TO SUCCESSFULLY TREAT THE PERFORATION. 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 582031

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention