BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 7549438 · Received May 29, 2018

    Report

    Report Number
    2024168-2018-03957
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    May 2, 2018
    Report Date
    May 29, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    UDI-DI
    08717648176401
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. THE ADDITIONAL 3.5 X 19 MM GRAFTMASTER DEVICE REFERENCED IN DESCRIBE EVENT OR PROBLEM AND CONCOMITANT MEDICAL PRODUCTS IS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT REFERENCE NUMBER. EVALUATION SUMMARY: A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED KINKED SHAFT 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. THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE TO ADVANCE, KINKED SHAFT AND SUBSEQUENT TREATMENT APPEAR 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFTMASTER STENTS WERE BEING USED TO TREAT A PERFORATION THAT OCCURRED DURING USE OF ANOTHER DEVICE. THE FIRST 3.5 X 19 MM GRAFTMASTER STENT DELIVERY SYSTEM (SDS) (LOT NUMBER 7052441) CROSSED AND THE STENT DEPLOYED SUCCESSFULLY; HOWEVER, DID NOT SEAL THE PERFORATION. THE SECOND 3.5 X 19 MM GRAFTMASTER SDS (LOT NUMBER 7052341) WAS NOT ABLE TO CROSS FOR TREATMENT OF THE PERFORATION WHICH RESULTED IN THE SHAFT OF THE DEVICE BECOMING KINKED. THE SDS WAS REMOVED WITHOUT ISSUE FROM THE PATIENT. A 3.5 X 16 MM GRAFTMASTER SDS WAS ABLE TO CROSS SUCCESSFULLY, THE STENT WAS DEPLOYED AND THE PERFORATION WAS SEALED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392502 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 7052341 08717648176401

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention STENT: 3.5 X 19 MM GRAFTMASTER