BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 8044022 · Received November 6, 2018

    Report

    Report Number
    2024168-2018-08536
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 12, 2018
    Report Date
    November 6, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    UDI-DI
    08717648176340
    PMA / PMN Number
    H000001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE CATHETER: XB 3.5. GUIDE WIRE: PT LOW, J WIRE. SHEATH: 7F PINNACLE. STENT: 2.5X26MM RESOLUTE OYX. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT 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

    A NON-ABBOTT 2.5 X 26 MM DRUG-ELUTING STENT WAS DEPLOYED IN THE PROXIMAL SECOND OBTUSE MARGINAL BRANCH; HOWEVER, POST-DEPLOYMENT ANGIOGRAPHY SHOWED A LARGE PERFORATION WITHIN THE STENTED PORTION. THE STENT DELIVERY CATHETER WAS ADVANCED BACK INTO THE STENT AND INFLATED AT LOW ATMOSPHERES. THE BALLOON TAMPONADE IN THE PERFORATION SEGMENT CONTINUED AT LOW PRESSURES FOR SEVERAL MINUTES. A 2.8X16MM GRAFTMASTER COVERED STENT WAS THEN ADVANCED INTO THE PROXIMAL LEFT CIRCUMFLEX ARTERY. THE BALLOON BEING USED TO TAMPONADE OFF THE PERFORATION WAS DEFLATED. ANGIOGRAPHY DID NOT SHOW ANY SIGNIFICANT EXTRAVASATION/PERFORATION AT THIS TIME. THE GRAFTMASTER COVERED STENT FAILED TO REACH THE LESION DUE TO THE DEPLOYED STENT. GIVEN THAT THERE WAS NO EXTRAVASATION, NO ADDITIONAL INTERVENTION WAS PERFORMED AND THE AREA IS BEING MONITORED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THIS WHOLE PROCEDURE WITHOUT CHEST PAIN OR ST CHANGES. THE GRAFTMASTER COVERED STENT DID NOT CAUSE OR CONTRIBUTE TO ANY COMPLICATIONS OR ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884670 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 8052441 08717648176340

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR