BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 8621524 · Received May 17, 2019

    Report

    Report Number
    2024168-2019-03919
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 9, 2018
    Report Date
    June 11, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER (B)(4).CORRECTION:LOT NUMBER WAS CORRECTED FROM 7073141 TO 7111541.EVALUATION SUMMARY:A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED SHAFT DETACHMENT WAS CONFIRMED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE TESTED AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. IT SHOULD BE NOTED THAT THE GRAFTMASTER RAPID EXCHANGE (RX), CORONARY STENT GRAFT SYSTEM, ELECTRONIC INSTRUCTIONS FOR USE, (EIFU) STATES: THE GRAFTMASTER RX IS A BALLOON-EXPANDABLE PRE-MOUNTED CORONARY STENT GRAFT FOR INTRALUMINAL CHRONIC PLACEMENT IN CORONARY ARTERIES OR AORTO-CORONARY BYPASS GRAFTS FOR THE TREATMENT OF CORONARY ARTERY ANEURYSM, CORONARY BYPASS-VEIN GRAFT ANEURYSM, ACUTE CORONARY ARTERY PERFORATION AND ACUTE CORONARY ARTERY RUPTURE. IT IS UNKNOWN IF THE IFU DEVIATION CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY THAT HAD A DISSECTION. A 2.8 X 19 MM GRAFTMASTER COVERED STENT WAS USED; HOWEVER, IT FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND THE HYPOTUBE SEPARATED. THEREFORE, ANOTHER UNSPECIFIED STENT WAS IMPLANTED TO TREAT THE DISSECTION, WHICH WAS NOT ACTIVELY BLEEDING. THERE WERE NO OTHER DEVICE ISSUES NOTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415161 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 7111541

    Patients

    Seq Age Sex Outcome Treatment
    1