BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 7139187 · Received December 21, 2017

    Report

    Report Number
    2024168-2017-10054
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    December 1, 2017
    Report Date
    December 21, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION BLUE; GUIDING CATHETER: HYPERION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. THE INVESTIGATION DETERMINED THE REPORTED FAILURE TO ADVANCE AND SUBSEQUENT TREATMENT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROTABLATION OF A MODERATELY TORTUOUS, HEAVILY CALCIFIED, 90% STENOSED, DISTAL RIGHT CORONARY ARTERY (RCA), A PERFORATION OCCURRED. AN UNSUCCESSFUL ATTEMPT WAS MADE TO TREAT THE PERFORATION WITH AN UNSPECIFIED BALLOON DILATATION CATHETER (BDC). A 2.80 X 26 MM GRAFTMASTER RX COVERED STENT WAS THEN SELECTED FOR TREATMENT. THE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, MET RESISTANCE WITH THE ANATOMY AND WOULD NOT CROSS. THE SDS WAS REMOVED FROM THE ANATOMY. ANOTHER BDC WAS ADVANCED TO THE PERFORATION, INFLATED, AND HEMOSTASIS WAS ACHIEVED. THE PROCEDURE WAS COMPLETED WITH THE SUCCESSFUL DEPLOYMENT OF AN UNSPECIFIED STENT IMPLANT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917829 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 7071041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention