BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 1078265 · Received July 16, 2008

    Report

    Report Number
    9616099-2008-01776
    Event Type
    Death
    Date Received
    July 16, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 20, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED SHOWING THAT THIS LOT OF PRODS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUAL PLAN. THE PT'S MEDICAL HISTORY PUTS THEM IN A HIGH-RISK CATEGORY FOR AN INVASIVE PROCEDURE. BASED ON THE INFO CONTAINED IN THE FILE, THERE IS NO EVIDENCE TO SUGGEST A RELATIONSHIP BETWEEN THE IMPLANTED PROD AND THE REPORTED EVENT OF PULMONARY HYPERTENSION.

    Description of Event or Problem · 1

    THE PT WAS A FEMALE WITH A HISTORY OF SEVERE PULMONARY DISEASE, HYPERLIPIDEMIA, COPD, SMOKING AND HYPERTENSION. THE TARGET LESION WAS THE RIGHT OSTIUM OF THE INTERNAL CAROTID. THE LESION HAD MILD CALCIFICATION AND TORTUOSITY. PRE-PROCEDURE STENOSIS WAS 85%. THE LESION WAS PRE-DILATED (SIZE BALLOON UNK). A PRECISE RX 8 X 30 MM STENT WAS DEPLOYED IN THE LESION WITH GOOD WALL APPOSITION. POST-PROCEDURE STENOSIS WAS 0%. NO THROMBUS WAS NOTED PRE OR POST PROCEDURE. IMMEDIATELY FOLLOWING THE PROCEDURE, STILL IN THE PROCEDURE ROOM, THE PT HAS SUDDEN CHEST PAIN, BRADYCARDIA, AND DROP IN BLOOD PRESSURE. THE PT WAS TREATED WITH ATROPINE AND FLUID RESUSITATION. THE CARDIOPULMONARY TEAM WAS CALLED IN. THE PT WAS INTUBATED. CATHETERIZATION SHOWED NO CORONARY ARTERY DISEASE. THE PT WAS DIAGNOSED WITH PULMONARY HYPOTENSION AND SENT TO THE MICU. THE PHYSICIAN CANNOT UNRELATE THE EVENTS FROM THE PRECISE STENT. THE PT PASSED AWAY 6 DAYS LATER IN THE MICU FROM PULMONARY HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13268338

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death