BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 1346422 · Received March 17, 2009

    Report

    Report Number
    2134265-2009-00994
    Event Type
    Death
    Date Received
    March 17, 2009
    Date of Event
    February 10, 2009
    Report Date
    February 18, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THE REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #2134265-2009-00997 AND 2134265-2009-00999. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT MIGRATION OCCURRED AND FOLLOWING THE PROCEDURE DEATH OCCURRED. THE TARGET STRICTURE WAS IN THE SUPERIOR VENA CAVA (SVC). APPROX 300 UNITS OF HEPARIN WAS ADMINISTERED INTRAVENOUSLY. AN UNKNOWN TYPE OF 10MMX4CM BALLOON CATHETER WAS ADVANCED THROUGH THE PT'S RIGHT GROIN AND WAS USED TO PREDILATE THE SVC. A 18X40/10FR UNI PLUS 100CM STENT WAS ADVANCED AND DEPLOYED IN THE SVC "ABOVE THE LEVEL OF OBSTRUCTION". DURING INITIAL DEPLOYMENT, THE SUPERIOR ASPECTS OF THE STENT DID NOT FLAIR APPROPRIATELY. AN UNSPECIFIED TYPE OF 10MMX4CM BALLOON CATHETER WAS USED TO DILATE THE SUPERIOR ASPECTS OF THE STENT; HOWEVER, DURING THIS PROCESS, IT APPEARED THAT THE STENT STRUT BECAME ENTANGLED IN THE BALLOON. AS THE BALLOON WAS WITHDRAWN, THE STENT MIGRATED CENTRALLY THROUGH THE TARGET LESION AND INTO THE SVC. AN UNSPECIFIED 10MM GOOSENECK SNARE WAS ADVANCED TO THE SVC VIA THE PT'S RIGHT INTERNAL JUGULAR VEIN. ATTEMPTS TO SNARE THE STENT WERE UNSUCCESSFUL. ATTEMPTS TO PUSH THE STENT BACK INTO THE SVC WITH A NON-BSC BALLOON CATHETER WERE ALSO UNSUCCESSFUL. THE PT'S LEFT GROIN WAS ACCESSED. A 20X40MM WALLSTENT WAS DEPLOYED IN THE SVC APPROX 2CM ABOVE THE STENOSIS; HOWEVER, THE TOP PORTION OF THE STENT DID NOT COMPLETELY FLARE AND THE STENT ALSO "SLIGHTLY MIGRATED" INTO THE RIGHT ATRIUM DURING DEPLOYMENT. THE DEPLOYMENT DEVICE BECAME ENTANGLED IN THE TOP PART OF THE STENT. THE DEPLOYMENT SHEATH WAS ABLE TO BE WITHDRAWN; HOWEVER, THE 20X40MM WALLSTENT ALSO MIGRATED THROUGH THE AREA OF STENOSIS INTO THE RIGHT ATRIUM. BOTH STENTS MIGRATED INTO THE ATRIUM AND BECAME FULLY DEPLOYED. DESPITE "PROLONGED MANIPULATION, MULTIPLE TECHNIQUES AND SNARING ATTEMPTS WITH A 25MM SNARE, THE STENTS WOULD NOT COLLAPSE". DESPITE 3 ACCESS SITES, THE STENTS COULD NOT BE RETRIEVED. A 22X45MM WALLSTENT WAS ADVANCED WAS DEPLOYED INSIDE OF THE PREVIOUSLY IMPLANTED WALLSTENTS TO KEEP THE 2 MIGRATED WALLSTENTS FROM MIGRATING FURTHER TO THE RIGHT VENTRICLE. THE STENTS WERE POST DILATED WITH A 16MMX4CM NON-BSC BALLOON WITH FLOW APPEARING "IMPROVED PRIOR FROM THE PRE-PROCEDURAL STENT PLACEMENT". DURING THE PROCEDURE THE PT BECAME AGITATED DUE TO A "FAIRLY LONG PROCEDURAL TIME". MODERATE CONSCIOUS SEDATION WAS ADMINISTERED FOR APPROX 4 HOURS. AT AN UNSPECIFIED TIME DURING SEDATION, THE PT BECAME "SOMEWHAT" UNRESPONSIVE AND HIS OXYGEN SATURATION DECREASED "TO 80%". THE PT WAS TREATED WITH FACEMASK OXYGEN AND WAS ADMINISTERED NARCAN. THE PT BECAME "RESPONSIVE" AND HIS OXYGEN SATURATION INCREASED "INTO THE 90'S". THE PT LOOKED "FAIRLY GOOD AND WAS RESPONSIVE WITHOUT ANY SIGNIFICANT PROBLEMS". ONE HOUR LATER, THE PT BECAME HYPOTENSIVE WITH "SOME DEGREE OF MENTAL CHANGE". THE PT WAS ALERT BUT SOMNOLENT AND TACHYCARDIC. THE PT COMPLAINED OF SHORTNESS OF BREATH, WHICH WAS NOTED PRIOR TO THE PROCEDURE. A "CONDITION C" WAS CALLED. INITIALLY, THE PT WAS SOMNOLENT BUT RESPONSIVE. THE PT WAS HAVING "DIFFICULTY OXYGENATING" AND WAS INTUBATED. THE PT WENT INTO PULSELESS ELECTRICAL ACTIVITY AND CARDIOPULMONARY RESUSCITATION WAS INITIATED. THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR FURTHER MANAGEMENT. AT AN UNSPECIFIED TIME LATER, THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| O| R 16MMX4CM ALTAS BALLOON| .0.35 SUPER STIFF AMPLATZ WIRE| 36MM CODA BALLOON