BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1951263 · Received January 6, 2011

    Report

    Report Number
    2024168-2011-00063
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 15, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE GRAFTMASTER STENT WAS USED AFTER ITS LABELED EXPIRATION DATE (USE BY DATE). BASED ON THE FINISHED PRODUCT DEVICE HISTORY RECORD, THE REPORTED LOT NUMBER 505764 IS ASSOCIATED WITH A 3 YEAR SHELF LIFE AND AN EXPIRATION DATE OF NOVEMBER 2010, WHICH IS 1 MONTH PRIOR TO THE REPORTED DATE OF OCCURRENCE (DECEMBER 14, 2010). THE GRAFTMASTER INSTRUCTIONS FOR USE STATES: USE THE DEVICE PRIOR TO THE USE BY DATE SPECIFIED ON THE PACKAGE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR USE AFTER EXPIRATION FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ALTHOUGH THE EXACT CAUSE OF WHY THE PRODUCT WAS USED AFTER EXPIRATION CANNOT BE DETERMINED FROM THE REPORTED INFORMATION, IT APPEARS THAT USE ERROR LIKELY CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DEVICE (B)(4) - USE AFTER EXPIRATION. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    REPORTEDLY THE SITE IMPLANTED THE EXPIRED GRAFTMASTER BECAUSE THEY DID NOT HAVE ANY OTHER GRAFTMASTER DEVICES AVAILABLE. THE ACCOUNT MANAGER VISITED THE SITE ON (B)(6) 2010, AND CHECKED THE GRAFTMASTER INVENTORY FOR EXPIRED STOCK AND PULLED THREE WHICH WERE EXPIRED. THAT EVENING HE RECEIVED A PHONE CALL FROM THE SITE INQUIRING ABOUT THE PACKAGE LABELING AND EXPIRATION DATE, BUT DID NOT MENTION ANY SPECIFIC CASE. ON (B)(6) 2010, THE ACCOUNT MANAGER RECEIVED ANOTHER PHONE CALL FROM THE SITE STATING THAT THEY HAD IMPLANTED THE 3.0 X 19 MM GRAFTMASTER EVEN THOUGH IT WAS EXPIRED BECAUSE THEY DID NOT HAVE ANY GRAFTMASTERS AVAILABLE DURING THE PROCEDURE. THERE HAVE BEEN NO PATIENT EFFECTS. THE PATIENT IS FINE AT THIS POINT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 505764

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR