BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 1111655 · Received August 12, 2008

    Report

    Report Number
    9616099-2008-01975
    Event Type
    Death
    Date Received
    August 12, 2008
    Date of Event
    March 9, 2008
    Report Date
    July 17, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 9616099-2008-01975 AND 9616099-2008-01976.

    Additional Manufacturer Narrative · 1

    THE PRODUCT(S) ARE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MFG ROUTE SHEETS FOR THE INVOLVED LOT(S) CONFIRMED THAT THE DEVICE(S) MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. BASED ON THE AVAILABLE INFO IT IS NOT POSSIBLE TO DETERMINE IF A RELATIONSHIP EXISTS BETWEEN THE CORDIS PRECISE STENTS AND THE REPORTED STROKE/MI/DEATH. THERE IS NO EVIDENCE TO SUGGEST THAT THIS IS RELATED TO A MFG ISSUE OR ANY OTHER DEFECT OF THE DEVICE. THIS IS ONE OF TWO REPORT SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT # 9616099-2008-01976.

    Description of Event or Problem · 1

    THIS PATIENT WITH A HISTORY OF MULTIPLE SCLEROSIS, SEVERE PULMONARY DISEASE, HYPERLIPIDEMIA, CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION, AND HYPERTENSION WAS ADMITTED FOR CAROTID STENTING. HE HAD HIS RIGHT INTERNAL CAROTID ARTERY STENTED WITH A 9.0 X 30MM PRECISE STENT. AT 30-DAY FOLLOW-UP, HE WAS NEUROLOGICALLY UNCHANGED AT THAT TIME. SIX MONTHS POST INDEX PROCEDURE, HE HAD THE LEFT INTERNAL CAROTID ARTERY STENTED WITH A 10 X 30MM PRECISE STENT. DURING THIS PROCEDURE, IT WAS NOTED THAT THE RIGHT ICA STENT WAS WIDELY PATENT. AT 1-YEAR PHONE FOLLOW-UP, THE PATIENT'S WIFE REPORTED THAT THE PATIENT HAD DIED AT HOME OF A STROKE AND A HEART ATTACK. SHE DID NOT GIVE ANY OTHER INFORMATION.

    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 13165499

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Death