BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1979474 · Received February 4, 2011

    Report

    Report Number
    2024168-2011-00665
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 11, 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).

    Additional Manufacturer Narrative · 1

    (B)(4): INDICATION FOR USE. THE 3.0 X 20 MM VOYAGER NC (1011754-20/UNK) IS BEING FILED UNDER A SEPARATE MFR NUMBER. THE DISLODGED STENT AND STENT DELIVERY SYSTEM WERE DISCARDED. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS 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, 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. FURTHERMORE, POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT WITHIN THE BODY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PRODUCT PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PRODUCT PREPARATION, AN INTERACTION WITH THE PATIENT ANATOMY, OR FROM AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT AND/OR ACCESSORY DEVICES. IN THIS CASE, SINCE THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE SDS OR STENT IMPLANT PRIOR TO THE PROCEDURE, THIS MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED. RETURN OF THE GRAFTMASTER MAY HAVE ULTIMATELY AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE REPORTED EVENT. IT IS POSSIBLE THAT THE STENT INTERACTED WITH THE ANATOMY AND/OR THE PREVIOUSLY IMPLANTED STENT DURING ATTEMPTED ADVANCEMENT SUCH THAT UPON REMOVAL, THE STENT BECAME DISRUPTED ON THE BALLOON AND DISLODGED, THOUGH THIS CANNOT BE CONFIRMED. THE REMOVAL OF THE FOREIGN BODY AND ADDITIONAL THERAPY/NON-SURGICAL TREATMENT APPEAR TO BE A SECONDARY EFFECTS OF THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT AS THE DISLODGED STENT WAS RETRIEVED WITH A SNARE DEVICE AND THE PATIENT RETURNED 3 DAYS LATER FOR FURTHER INTERVENTION. REPORTEDLY, THE GRAFTMASTER WAS USED IN ATTEMPT TO TREAT A DISSECTION. IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTIONS FOR USE (IFU) STATES: THE JOSTENT GRAFTMASTER IS INDICATED FOR USE IN THE TREATMENT OF FREE PERFORATIONS, DEFINED AS FREE CONTRAST EXTRAVASATION INTO THE PERICARDIUM, IN NATIVE CORONARY VESSELS OR SAPHENOUS VEIN BYPASS GRAFTS LES THAN OR EQUAL TO 2.75 MM IN DIAMETER. BASED ON THE INFORMATION RECEIVED, THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. HOWEVER, WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORT STENT DISLODGEMENT CANNOT BE DETERMINED. 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 PRODUCT QUALITY, INCLUDING STENT DISLODGEMENT FORCE AS WELL AS PROPER GUIDE WIRE AND GUIDING CATHETER MOVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: NAME, ADDRESS AND PHONE NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING CORONARY INTERVENTION ON (B)(6) 2011 TO HIS SAPHENOUS VEIN GRAFT (SVG) TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY FOR THE TREATMENT OF RESTENOSIS OF A NON-ABBOTT STENT. A DISSECTION WAS NOTED AFTER PRE DILATATION OF A THE RESTENOSED STENT WITH THE VOYAGER NC. THE DECISION WAS MADE TO USE A GRAFTMASTER STENT TO TREAT THE DISSECTION OF THE SVG TO THE LAD. THE GRAFTMASTER WOULD NOT CROSS, AND DURING REMOVAL FROM THE PATIENT, THE STENT IMPLANT DISLODGED AND WAS REMOVED WITH A SNARE DEVICE. THE PATIENT DID WELL AND THE DISSECTION HEALED WITHOUT FURTHER INTERVENTION. THE PATIENT WAS RETURNED TO THE CATH LAB ON (B)(6) 2011 FOR TREATMENT OF THE SVG TO LAD. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 IN STABLE CONDITION. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention DIL CATH: 3.0 X 20 MM VOYAGER NC (1011754-20/UNK)