BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1933387 · Received December 20, 2010

    Report

    Report Number
    2024168-2010-02829
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 23, 2010
    Manufacturer
    AV-RANGENDINGEN
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE IT WAS NOT RETURNED TO ABBOTT VASCULAR FOR EVALUATION. FAILURE TO SEAL THE PERFORATION (THE REPORTED LEAK) MAY BE ATTRIBUTED TO SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, STENT GRAFT FOIL DAMAGE, PATIENT ANATOMICAL MORPHOLOGY, PRODUCT SIZE SELECTION, DEPLOYMENT TECHNIQUE (NON-CENTRAL POSITIONING OF STENT GRAFT OVER PERFORATION OR INADEQUATE OVERLAPPING), INTERFERENCE FROM PREVIOUSLY DEPLOYED DEVICES, OR GROWTH OF PERFORATION DURING DEPLOYMENT. DURING MANUFACTURING, ALL STENT DELIVERY SYSTEMS (SDS) ARE 100% LEAK-TESTED AND VISUALLY INSPECTED FOR FOIL DAMAGE AND PROPER PLACEMENT. THE STENT REMAINS IN THE ANATOMY, AND THE PRODUCT WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. IT IS POSSIBLE THAT THE STENTS WERE NOT POSITIONED CORRECTLY IN THE ANATOMY TO PROPERLY SEAL THE PERFORATION. HOWEVER AS THIS CANNOT BE CONFIRMED, A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO SEAL THE PERFORATION CANNOT BE DETERMINED. IT WAS REPORTED THAT, AFTER THE GRAFTMASTER STENT WAS IMPLANTED, THE PATIENT EXPERIENCED CARDIOGENIC SHOCK AND CARDIAC TAMPONADE. DUE TO THE INHERENTLY SERIOUS AND EMERGENT USE OF THE GRAFTMASTER DEVICE, THE PERFORATION ITSELF AND/OR THE FAILURE TO TREAT THE PERFORATION MAY HAVE POSSIBLY RESULTED IN CASCADE OF PATIENT EFFECTS AND ADDITIONAL TREATMENTS. THE PATIENT WAS SENT FOR SURGERY; HOWEVER LATER PASSED AWAY. DEATH IS LISTED IN THE OTW GRAFTMASTER INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THESE REPORTED PATIENT EFFECTS AND THEIR RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ALTHOUGH A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED FAILURE TO SEAL AND THE REPORTED PATIENT EFFECTS, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE JOSTENT GRAFTMASTER, PART# 12744-16, LOT 556452 WILL BE REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING PROCEDURE IN THE RIGHT CORONARY ARTERY (RCA), A PERFORATION OCCURRED BY AN UNSPECIFIED NON-ABBOTT DEVICE. TWO GRAFTMASTER STENTS WERE SUCCESSFULLY DEPLOYED FOR TREATMENT OF THE PERFORATION; HOWEVER, THE PERFORATION WAS NOT SEALED. THE PATIENT WHEN INTO CARDIOGENIC SHOCK AND CARDIAC TAMPONADE. CORONARY ARTERY BYPASS GRAFT SURGERY (CABG)WAS PERFORMED. THE PATIENT DIED (B)(6) 2010. THE CAUSE OF DEATH WAS REPORTED AS A CARDIAC EVENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-RANGENDINGEN 588163

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death JOSTENT GRAFTMASTER, PART 12744-16, LOT 556452