BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2117086 · Received June 8, 2011

    Report

    Report Number
    2024168-2011-04013
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. (B)(4): STENT: 4.5 X 16 MM OTW GRAFTMASTER; 4 X 28 MM OTW XIENCE V. EMBOLIC PROTECTION: SPIDER EX. (B)(4) - INDICATION FOR USE. THE STENT REMAINS IN THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY DURING USE OF THE DEVICES. EMBOLI, TOTAL OCCLUSION, AND MYOCARDIAL INFARCTION ARE LISTED AS KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY STENT GRAFT IN THE GRAFTMASTER OTW INSTRUCTIONS FOR USE (IFU). THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. IT SHOULD BE NOTED THAT THE PRODUCT IFU STATES: THE JOSTENT GRAFTMASTER IS INDICATED FOR USE IN THE TREATMENT OF FREE PERFORATIONS, DEFINED AS FREE CONTRAST EXTRAVASATION INTO THE PERICARDIUM, IN NATIVE CORONARY VESSELS OR SAPHENOUS VEIN BYPASS GRAFTS. THE SAFETY OF THE JOSTENT GRAFTMASTER HAS NOT BEEN ESTABLISHED FOR PATIENTS WITH UNRESOLVED VESSEL THROMBUS AT THE LESION SITE. IT IS POSSIBLE THAT ATTEMPTING TO TREAT UNRESOLVED THROMBUS WITH THE GRAFTMASTER STENTS CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO GRAFTMASTERS AND ONE XIENCE V STENT WERE SUCCESSFULLY IMPLANTED IN THE SAPHENOUS VEIN GRAFT TO THE RIGHT POSTERIOR DESCENDING ARTERY CONTAINING A LARGE AMOUNT OF THROMBUS. THE COVERED STENTS WERE USED TO TRY AND LIMIT THE ANTICIPATED DISTAL EMBOLIZATION OF THROMBUS. ADDITIONAL EFFORTS TO CONTAIN THE THROMBUS INCLUDED USING A NON-ABBOTT DISTAL EMBOLIZATION PROTECTION DEVICE THAT BECAME OVERWHELMED WITH DEBRIS. MANUAL ASPIRATION OF THROMBUS WAS ALSO PERFORMED; HOWEVER, NO REFLOW STILL OCCURRED. AFTER THE PROCEDURE, THE PATIENT WAS FOUND TO HAVE AN ASYMPTOMATIC, POST PROCEDURAL INFARCTION WITH THE ENZYME ASSAY. THE PHYSICIAN INDICATED THAT COMPLETE ELIMINATION OF DISTAL EMBOLIZATION WAS NOT A REALISTIC GOAL. THE PATIENT RECOVERED AND WAS DISCHARGED HOME 48 HOURS LATER. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 673452

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R| S