BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2113672 · Received June 3, 2011

    Report

    Report Number
    2024168-2011-03875
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    July 15, 2010
    Report Date
    May 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. THE STENT REMAINS IN THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THROMBOSIS IS A KNOWN ADVERSE EVENT AS LISTED IN THE GRAFTMASTER OTW INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICES CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN. A REVIEW OF THE LOT HISTORY RECORD WAS NOT PERFORMED AS THERE WAS NO REPORTED PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A 3.0 X 18 MM NON-ABBOTT STENT IMPLANTED IN THE MID CIRCUMFLEX IN 2006. ON (B)(6) 2010, THE PATIENT RETURNED WITH AN ACUTE MYOCARDIAL INFARCTION AND OCCLUSION OF THE NON-ABBOTT STENT. BALLOON DILATATIONS WERE PERFORMED WITH AN UNSPECIFIED BALLOON AND A NON-ABBOTT ASPIRATION CATHETER WAS USED. A DISTAL DISSECTION WAS NOTED AND A PERFORATION WAS NOTED IN THE AREA OF THE NON-ABBOTT STENT. THE 3.0 X 16 MM GRAFTMASTER WAS PLACED PARTIALLY OVERLAPPING THE NON-ABBOTT STENT TO TREAT THE PERFORATION AND DISSECTION. THE PROCEDURE WAS COMPLETED AND THE PATIENT LEFT THE CATH LAB AND WAS MOVED TO A UNIT. APPROXIMATELY 10 HOURS LATER, THE PATIENT WAS RETURNED TO THE CATH LAB WITH IN-STENT THROMBOSIS IN THE MID CIRCUMFLEX. TREATMENT WAS PERFORMED FOR THE THROMBOSIS VIA BALLOONING, A NON-ABBOTT THROMBECTOMY CATHETER AND PLACEMENT OF A NON-ABBOTT STENT. THE PROCEDURE WAS SUCCESSFUL. THE FINAL PATIENT OUTCOME WAS REPORTED TO BE GOOD. NO FURTHER PATIENT EFFECTS WERE REPORTED. 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 495342

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention STENT: 3.0 X 18 MM CYPHER