BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2060226 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02660
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    April 2, 2009
    Report Date
    March 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THE JOSTENT GRAFTMASTER 3.0 X 19 STENT IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. 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, 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. 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 REPORTED EVENT. THE RETURN OF THE GRAFTMASTER SDS MAY HAVE ULTIMATELY AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE REPORTED EVENT. IT IS POSSIBLE THAT THE STENT INTERACTED WITH THE ANATOMY DURING ATTEMPTED ADVANCEMENT SUCH THAT UPON REMOVAL, THE STENT BECAME DISRUPTED ON THE BALLOON AND DISLODGED, THOUGH THIS CANNOT BE CONFIRMED. 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 PRODUCT QUALITY, INCLUDING STENT DISLODGEMENT FORCE AS WELL AS PROPER GUIDE WIRE AND GUIDING CATHETER MOVEMENT. 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 COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE LOT NUMBER WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT THE RIGHT CORONARY ARTERY, A PERFORATION OCCURRED DURING USE OF A NON-ABBOTT ATHERECTOMY DEVICE. A 3.0 AND 3.5 BALLOON WERE USED TO TAMPANADE THE VESSEL. AT THIS TIME THE PATIENT WAS HEMODYNAMICALLY STABLE, WITH BLOOD PRESSURE MAINTAINED. PROTAMINE WAS GIVEN TO FLUSH THE HEPARIN. A 3.0 X 19 GRAFTMASTER WAS ATTEMPTED TO TREAT THE PERFORATION; HOWEVER, EVEN WITH A BUDDY WIRE SYSTEM, THE DEVICE WOULD NOT CROSS. A 3.0 X 12 GRAFTMASTER WAS THEN ATTEMPTED TO BE ADVANCED, BUT IT WOULD NOT CROSS THE LESION. DURING REMOVAL, THE STENT DISLODGED FROM THE BALLOON, AND WAS CONFIRMED TO BE IN THE MID RCA. IT WAS DECIDED THAT THE PATIENT WOULD BE SENT FOR CORONARY ARTERY BY-PASS SURGERY FOR DRAINAGE OF THE PERICARDIAL SAC. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM 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 75 YR Hospitalization| R GUIDE CATH: 6F JR 4.0SHEATH: PINNACLE