BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2995446 · Received March 8, 2013

    Report

    Report Number
    2024168-2013-01362
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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. CONCOMITANT PRODUCTS: GUIDE WIRE: PT2; GUIDE CATH: 6F Q 3.5. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF THROMBOSIS IS ALSO A KNOWN ADVERSE EVENT AS LISTED IN THE GRAFT MASTER OTW INSTRUCTION FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID LEFT ANTERIOR DESCENDING ARTERY. A PERFORATION OCCURRED WITH AN UNKNOWN DEVICE. A 3.0 X 19 MM OTW GRAFTMASTER WAS SUCCESSFULLY USED TO SEAL THE PERFORATION. HOWEVER, WHEN THE PERFORATION OCCURRED, ANGIOMAX WAS DISCONTINUED AND 1 1/2 TO 2 HOURS AFTER THE PROCEDURE, THE PATIENT HAD NAUSEA AND DIAPHORESIS AND THE ECHOCARDIOGRAM SHOWED ST-ELEVATION ANTERIORLY. ANGIOGRAPHY REVEALED THAT THROMBOSIS HAD OCCURRED IN THE GRAFTMASTER AND TWO DRUG ELUTING STENTS WERE DEPLOYED DISTAL TO AND IN THE PREVIOUS DEPLOYED STENTS. THE PATIENT IS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98552 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 688997

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention