BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3251004 · Received July 29, 2013

    Report

    Report Number
    2024168-2013-04731
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: RUNTHROUGH; GUIDE CATH: ENVOY 7 FR; SHEATH: TERUMO 7 FR; STENT: GRAFTMASTER. (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THE LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE RX GRAFTMASTER INSTRUCTIONS FOR USE (IFU) STATES THAT THE JOSTENT GRAFTMASTER IS A BALLOON-EXPANDABLE PRE-MOUNTED CORONARY STENT GRAFT FOR INTRALUMINAL CHRONIC PLACEMENT IN CORONARY ARTERIES OR AORTO-CORONARY BYPASS GRAFTS FOR THE TREATMENT OF CORONARY ARTERY ANEURYSM, CORONARY BYPASS-VEIN GRAFT ANEURYSM, ACUTE CORONARY ARTERY PERFORATION AND ACUTE CORONARY ARTERY RUPTURE. ALSO IN THE IFU: IF RESISTANCE IS FELT DURING MANIPULATION, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. IT SHOULD BE NOTED THAT THE RX GRAFTMASTER IFU STATES TO USE THE DEVICE PRIOR TO THE USE BY DATE SPECIFIED ON THE PACKAGE.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE FOR TREATMENT OF A CAROTID CAVERNOUS FISTULA, A 4.5X16 GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT RESISTANCE WAS FELT DUE TO TORTUOSITY AND HEAVY CALCIFICATION. AFTER SEVERAL ATTEMPTS TO ADVANCE THE SDS, THE PROXIMAL SHAFT SEPARATED OUTSIDE OF THE ANATOMY. THE CATHETER WAS SIMPLY WITHDRAWN FROM THE GUIDE CATHETER. AFTER WITHDRAWAL, THE STENT STRUTS WERE NOTED TO BE FLARED. ANOTHER SAME SIZE GRAFTMASTER SDS WAS ADVANCED WITH DIFFICULTY DUE TO THE SIGNIFICANT TORTUOSITY; HOWEVER, THE STENT WAS DEPLOYED AND THE PROCEDURE WAS SUCCESSFUL. THE PATIENT CONDITION IS REPORTED AS GOOD. THERE WAS NO CLINICALLY SIGNIFICANT DELAY DUE TO THE FAILURE TO CROSS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SECOND GRAFTMASTER INDICATES THAT THE DEVICE WAS USED AFTER EXPIRATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354086 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 682996

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR