BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTMASTER

    MDR report key: 19010369 · Received April 1, 2024

    Report

    Report Number
    2024168-2024-03936
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    March 14, 2024
    Report Date
    June 28, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MAF
    UDI-DI
    08717648176357
    PMA / PMN Number
    H000001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6- MEDICAL DEVICE PROBLEM CODE 2017 CLARIFIER: USE AFTER EXPIRATION MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ELECTRONIC LOT HISTORY RECORD (ELHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HANDLING DATABASE IDENTIFIED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. REPORTEDLY, THE 2.80X19MM GRAFTMASTER STENT WAS USED AFTER THE EXPIRATION DATE. IT SHOULD BE NOTED THAT THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM INSTRUCTIONS FOR USE STATES: NOTE THE PRODUCT ¿USE BY¿ DATE SPECIFIED ON THE PACKAGE. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO DEVIATION OF THE INSTRUCTIONS FOR USE AS THE DEVICE WAS USED AFTER THE USE BY DATE. AS REPORTED, THE ACCOUNT CONFIRMED THE EXPIRATION DATE PRIOR TO USE; HOWEVER, AS IT WAS AN EMERGENCY SITUATION, THE STENT WAS IMPLANTED ANYWAY. PER THE PHYSICIAN THE IMPLANTATION OF THE STENT SAVED THE PATIENT¿S LIFE. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4: MODEL NUMBER UPDATED FROM NA TO 1012580-19.

    Description of Event or Problem · 0

    IT WAS REPORTED THE 2.80X19MM GRAFTMASTER STENT WAS USED AFTER THE EXPIRATION DATE. THE ACCOUNT CONFIRMED THE EXPIRATION DATE PRIOR TO USE; HOWEVER AS IT WAS AN EMERGENCY SITUATION, THE STENT WAS IMPLANTED ANYWAY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361083 GRAFTMASTER CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR INC. 1012580-19 2032241 08717648176357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown