BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2063577 · Received April 19, 2011

    Report

    Report Number
    2024168-2011-02752
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE GRAFTMASTER 3.5 X 19 MM IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE SHAFT, STENT IMPLANT AND FOIL. THERE WAS CONTRAST ON THE STENT. THIS IS CONSISTENT WITH HANDLING AND THE STENT DELIVERY SYSTEM (SDS) ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE BALLOON AND LOCATED ON THE BALLOON WHERE IT WAS ORIGINALLY CRIMPED. THERE WERE BENT PROXIMAL STRUTS ON THE FIRST ROW OF THE STENT IMPLANT. THE FOIL WAS STRETCHED AT THE BENT STRUTS. THE STENT OUTER DIAMETERS WERE MEASURED AND THE SDS WAS ADVANCED THROUGH A NEW 6FR GUIDING CATHETER WITH SLIGHT RESISTANCE NOTED AT THE DAMAGED STRUTS ON THE STENT IMPLANT. 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, AND ACCESSORY DEVICE SUPPORT. THE PATIENT ANATOMY WAS HEAVILY TORTUOUS, WHICH LIKELY CONTRIBUTED TO THE FAILURE TO ADVANCE AND SUBSEQUENT DAMAGE TO THE STENT, AS THERE WAS NO DAMAGE NOTED TO THE STENT PRIOR TO USE. ADDITIONALLY, DAMAGE TO THE PROXIMAL END OF THE STENT IS MOST CONSISTENT WITH THAT OF WHICH OCCURS AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE TIP OF THE GUIDING CATHETER AND/OR RHV DURING RETRACTION OF THE SDS. IT IS LIKELY THAT THE STENT CAUGHT ON THE TIP OF THE GUIDING CATHETER, FURTHER DAMAGING THE PROXIMAL STRUTS AND FOIL, CONTRIBUTING TO THE DIFFICULTY REMOVING THE SDS THROUGH THE GUIDING CATHETER. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE GRAFTMASTER DEVICES WERE USED IN AN ATTEMPT TO TREAT A PERFORATION LOCATED IN A SAPHENOUS VEIN GRAFT TO THE DIAGONAL AND 1ST OBTUSE MARGINAL, DESCRIBED AS HIGHLY TORTUOUS. THE PERFORATION WAS REPORTEDLY CAUSED BY A 3.75 X 20 MM NON-ABBOTT BALLOON DILATATION CATHETER DURING POST-DILATATION OF A NON-ABBOTT STENT AT 24 ATMOSPHERES. A 3.0 X 19 MM AND A 3.5 X 19 MM OTW GRAFTMASTER FAILED TO CROSS AND WERE DAMAGED DURING RETRACTION INTO THE GUIDING CATHETER; HOWEVER, THE THIRD GRAFTMASTER, A 4.0 X 19 MM, SUCCESSFULLY CROSSED AND SEALED THE PERFORATION. THE 3.5 X 19 MM GRAFTMASTER WAS NOTED TO HAVE A FLARED STRUT ONCE WITHDRAWN FROM THE PATIENT. THE PATIENT WAS REPORTEDLY DOING GREAT THE NEXT MORNING. AN ECHO WAS PERFORMED AND NO EFFUSION WAS SEEN. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 552336

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention STENT: ENDEAVOR