BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1904274 · Received November 12, 2010

    Report

    Report Number
    2024168-2010-02444
    Event Type
    Death
    Date Received
    November 12, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ABBOTT VASCULAR GERMANY
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (ABOVE THE RATED BURST PRESSURE) - (B)(4). THE JOSTENT GRAFTMASTER PART #12744-16, LOT #UNK AND THE XIENCE V EVEROLIMUS ELUTING STENT SYSTEM PART #1009542-15, LOT #0062341, (B)(4) INDICATED ARE BEING FILED UNDER SEPARATED MEDWATCH MFR NUMBERS. EVALUATION SUMMARY: 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% INSPECTED FOR STENT AND FOIL DAMAGE AS WELL AS PROPER STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER STENT DEPLOYMENT INCLUDING VISUAL INSPECTION FOR FOIL DAMAGE. THE DEVICE REGISTRATION FORM LISTED A MAXIMUM DEPLOYMENT PRESSURE OF 12 ATM FOR THE GRAFTMASTER STENT. IT SHOULD BE NOTED THAT THE GRAFTMASTER OTW INSTRUCTIONS FOR USE (IFU) STATES: "GENTLY DEPLOY THE STENT GRAFT BY SLOWLY INFLATING THE BALLOON TO A MINIMUM OF 14 ATM TO EXPAND THE STENT GRAFT". IT IS POSSIBLE THAT THE 3.0 X 16 GRAFTMASTER STENT WAS NOT EXPANDED SUFFICIENTLY FOR PROPER SEALING WITH THE VESSEL WALL, PARTICULARLY WHEN DEPLOYING AGAINST A DEPLOYED STENT; HOWEVER, AS THIS CANNOT BE CONFIRMED, A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED LEAK. DUE TO THE INHERENTLY SERIOUS AND EMERGENT USE OF THE GRAFTMASTER DEVICE, IT IS POSSIBLE THAT THE PERFORATION ITSELF AND/OR FAILURE TO SEAL THE PERFORATION MAY HAVE CONTRIBUTED TO THE REPORTED CASCADING PATIENT EFFECTS THAT ULTIMATELY RESULTED IN THE PATIENT'S DEATH. PERFORATION AND DEATH ARE LISTED AS POTENTIAL ADVERSE EVENTS IN THE GRAFTMASTER IFU, WHICH REASONABLY COVERS CARDIAC TAMPONADE AND CARDIAC ARREST AS THEY ARE ASSOCIATED CASCADING PATIENT EFFECTS OF AN UNTREATED PERFORATION. AS THESE REPORTED PATIENT EFFECTS MAY ALSO BE ATTRIBUTED TO THE PATIENT'S OVERALL HEALTH CONDITION, THE INITIAL PERFORATION ITSELF AND/OR PERFORATION TREATMENT STRATEGY, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THEIR RELATIONSHIP, IF ANY, TO THE DEVICE CANNOT BE DETERMINED. IN THIS CAUSE, ALTHOUGH A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED LEAK (FAILURE TO SEAL) OR THE REPORTED PATIENT EFFECTS, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY OF DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PREDILATATION OF THE LESION, DURING THE DEPLOYMENT OF THE XIENCE V STENT, A PERFORATION OCCURRED. TWO GRAFTMASTER STENTS WERE PLACED TO TREAT THE PERFORATION; HOWEVER, EXTRAVASATION CONTINUED INTO THE PERICARDIUM AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE FOR WHICH CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED; HOWEVER, THE PATIENT SUBSEQUENTLY EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR GERMANY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death XIENCE V EVEROLIMUS ELUTING STENT SYSTEM:| JOSTENT GRAFTMASTER: PART #12744-16, LOT #UNK| PART #1009542-15, LOT #0062341, (B)(4)