BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2120737 · Received June 10, 2011

    Report

    Report Number
    2024168-2011-04129
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. FAILURE TO ADVANCE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY (TORTUOSITY OR CALCIFICATION), PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION, ACCESSORY DEVICE SUPPORT, OR INTERACTION WITH ACCESSORY DEVICES OR PREVIOUSLY DEPLOYED DEVICES. THROUGHOUT THE MANUFACTURING PROCESS, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR CATHETER AND STENT DAMAGE. IT WAS NOTED THE TAKE OFF AT THE OBTUSE MARGINAL WAS AT AN OBTUSE ANGLE, WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE AND STIFF FEELING OF THE DEVICE AROUND A DIFFICULT ANGLE. AS THE GRAFTMASTER STENT WAS UNABLE TO CROSS, THE PERFORATION REMAINED UNTREATED AND CONTINUED TO BLEED (HEMORRHAGE). THE PATIENT WAS SENT TO SURGERY WHICH REQUIRED HOSPITALIZATION. 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 FAILURE TO ADVANCE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERFORATION IN THE OCCLUDED FIRST OBTUSE MARGINAL (OM1) WAS CAUSED BY A NON-ABBOTT CUTTING BALLOON. THE TAKE OFF TO THE OM1 WAS AT AN OBUSE ANGLE AND THE PHYSICIAN FELT IT WOULD BE DIFFICULT TO GET ANYTHING INTO THE PERFORATED LESION. ADDITIONALLY, THE PHYSICIAN STATED THE DEVICE FELT STIFF. A 3.0X12MM JOSTENT GRAFTMASTER WAS ATTEMPTED, BUT FAILED TO CROSS THE LESION. THE PATIENT WAS TAKEN TO SURGERY FOR TRIPLE CORONARY ARTERY BYPASS SURGERY. THE PATIENT TOLERATED THE PROCEDURE WELL AND REMAINS IN THE INTENSIVE CARE UNIT. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 675787

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R| S