BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 8139916 · Received December 6, 2018

    Report

    Report Number
    2024168-2018-09421
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    November 12, 2018
    Report Date
    February 13, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER - (B)(4). CORRECTION: LOT NUMBER HAS BEEN CHANGED FROM 8062541 TO UNKNOWN. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO CIRCUMSTANCES 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. IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER GRAFTMASTER DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN AN UNSPECIFIED CORONARY ARTERY. A 2.8 X 16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED; HOWEVER, IT DID NOT SEAL THE PERFORATION COMPLETELY. THEREFORE, AN ATTEMPT WAS MADE TO ADVANCE A 2.8 X 26 MM GRAFTMASTER COVERED STENT; HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AS IT COULD NOT CROSS THROUGH THE FIRST COVERED STENT. IT WAS REPORTED THAT THE PERFORATION WAS SEALED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979003 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 8062541

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention STENT: GRAFTMASTER 2.8X16.| STENT: GRAFTMASTER 2.8X16