BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3140931 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03431
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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. THE XIENCE XPEDITION REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75 X 38 MM XIENCE XPEDITION WAS IMPLANTED IN THE PROXIMAL LAD CAUSING A PERFORATION. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON CATHETER AND A 3.0 X12 GRAFTMASTER WAS ADVANCED TO THE PERFORATION BUT COULD NOT CROSS. SEVERAL PROLONGED INFLATIONS OF A BALLOON CATHETER LED TO PROXIMAL LAD THROMBOSIS WHICH SEALED THE PERFORATION. THE PATIENT DEVELOPED ATRIAL FIBRILLATION AND WAS TREATED WITH MEDICATION. POST PROCEDURE THE PATIENT HAD COMPLETE HEART BLOCK AND A MASSIVE MYOCARDIAL INFARCTION SECONDARY TO LARGE LAD PERFORATION. ON (B)(6) A PACEMAKER WAS PLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245318 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 726926

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention