BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM

    MDR report key: 549271 · Received October 15, 2004

    Report

    Report Number
    6000093-2004-01277
    Event Type
    Malfunction
    Date Received
    October 15, 2004
    Date of Event
    September 13, 2004
    Report Date
    September 17, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PT WAS ENROLLED IN THE ARRIVE PROGRAM MAR 2004. TARGET LESION 1 WAS IDENTIFIED IN THE 2ND DIAG WITH 90% STENOSIS AND A 2.75 MM REFERENCE VESSEL DIAMETER. TARGET LESION 1 WAS TREATED WITH PREDILATATION AND PLACEMENT OF A 2.5 X 20 M TAXUS STENT. RESIDUAL STENOSIS WAS 0% FOLLOWING POST-DILATATION. THE PT WAS DISCHARGED TO A NURSING FACILITY FOR REHABILITATION MAR 2004 ON ASA AND PLAVIX. THE PT WAS TAKEN TO THE ER IN APR 2004 WITH SHORTNESS OF BREATH, ELEVATED POTASSIUM AND ACUTE RENAL FAILURE. CHEST X-RAY SHOWED QUESTIONABLE RIGHT LOBE PNEUMONIA. CK'S WERE ELEVATED AT 11,000, CK-MB'S WERE 155.3 WITH AN INDEX OF 1.3 AND TROPONIN LEVEL WAS 0.49 (SITE CONFIRMED CK ELEVATION WAS DUE TO RHABDOMYOLYSIS). EKG REVEALED NORMAL SINUS RHYTHM. THE PT WAS ADMITTED TO THE ICU, AND UNDERWENT DIALYSIS DUE TO RENAL FAILURE. IN APR 2004, THE PT WISHED TO BE LEFT ALONE WITH COMFORT CARE MEASURES ONLY. DNR WAS INSTATED. THE PT WAS SEEN BY HOSPICE IN APR 2004 AND WAS TRANSFERED TO INPATIENT HOSPICE. THE PT EXPIRED IN APR 2004 (37 DAYS POST ARRIVE ENROLLMENT). DEATH CERTIFICATE STATES CARDIOMYOPATHY AS THE CAUSE OF DEATH. THERE WAS NO AUTOPSY PERFORMED. IN THE OPINION OF THE PHYSICIAN THE RELATIONSHIP FO THE EVENT TO THE TARGET VESSEL INVOLVED IS "UNK".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LEFT RENAL ARTERY PTA/STENT TREATMENT PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. RESISTANCE WAS ENCOUNTERED WHILE REMOVING THE EXPRESS BILIARY SD DELIVERY CATHETER THROUGH THE 8 FRENCH GUIDE CATHETER. FOLLOWING DEFLATION THE BALLOON APPEARED TO RE-WRAP INCORRECTLY. THE DELIVERY CATHETER WAS REMOVED AS A UNIT WITH THE BALLOON CATHETER AND GUIDEWIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. IT WAS REPORTED THAT THERE WAS "NO HARM" TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM PREMOUNTED BALLOON EXPANDABLE STENT SYSTEM FGE BOSTON SCIENTIFIC NA 6723405

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention