BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1659695 · Received April 13, 2010

    Report

    Report Number
    3004742046-2010-00147
    Event Type
    Death
    Date Received
    April 13, 2010
    Date of Event
    December 31, 2009
    Report Date
    March 19, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE STENT REMAINS IN THE PT. PER THE RX ACCULINK INSTRUCTIONS FOR USE (IFU) HYPOTENSION, MYOCARDIAL INFARCTION, ATRIAL FIBRILLATION, AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE DEVICE. THERE WAS NO KNOWN DEVICE PROBLEM REPORTED AND NO PRODUCT QUALITY DISCREPANCIES REPORTED DURING INSPECTION PRIOR TO USE. IN THIS CASE, THE INFO AVAILABLE AND RELEVANT MANUFACTURING RECORDS ARE NOT SUFFICIENT TO DETERMINE RELATION BETWEEN PT ADVERSE EVENTS AND THE ABBOTT VASCULAR DEVICE QUALITY. ALTHOUGH A CONCLUSIVE CAUSE COULD NOT BE IDENTIFIED, THE EVENT IS POSSIBLY RELATED TO THE PT'S DISEASE STATE AND OPERATIONAL CONTEXT OF THE DEVICE.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: ATRIAL FIBRILLATION, HYPOTENSION, MYOCARDIAL INFARCTION, DEATH. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED THAT PRIOR TO ADMISSION, THE PT HAD A STROKE ON (B) (6) 2009, THAT AFFECTED THE HEMISPHERE SUPPLIED BY THE RIGHT CAROTID ARTERY. THE PT WAS ADMITTED TO THE HOSPITAL ON (B) (6) 2009, WITH MULTIPLE MEDICAL CONDITIONS (STROKE, ASPIRATION PNEUMONIA, HYPERNATREMIA, CHRONIC RENAL INSUFFICIENCY, HYPERGLYCEMIA, AND RIGHT INTERNAL CAROTID ARTERY STENOSIS OF 80 TO 90%). PRE-PROCEDURE ASSESSMENT OF THE TARGET VESSEL IDENTIFIED A THROMBUS. ON (B) (6) 2009, THE PT UNDERWENT STENTING IN THE PREDILATED HEAVILY CALCIFIED RIGHT INTERNAL CAROTID/COMMON CAROTID ARTERY WITH AN ACCULINK STENT. AFTER THE CAROTID PROCEDURE, THE PT RECOVERED SOME FUNCTION OF HIS LEFT LEG. ON (B) (6) 2009, THE PT WAS NEWLY DIAGNOSED WITH ATRIAL FIBRILLATION, HYPOTENSION, AND A MYOCARDIAL INFARCTION. THE PT WAS TREATED WITH LOVENOX; ASPIRIN AND COUMADIN WERE HELD. ON (B) (6) 2010, THE PT WAS DISCHARGED HOME TO HOSPICE CARE WITH ONLY MORPHINE AND OXYGEN AND DIED OF UNSPECIFIED CAUSE ON (B) (6) 2010. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9010851

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death HEPARIN| (1011649-75, LOT# 9022451)| EMBOLIC PROTECTION: RX ACCUNET