BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1679517 · Received May 11, 2010

    Report

    Report Number
    9616099-2010-00354
    Event Type
    Death
    Date Received
    May 11, 2010
    Date of Event
    September 16, 2009
    Report Date
    April 30, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE STUDY COORDINATOR AT THE SITE REGARDING THE PATIENT'S DEATH. THE STUDY COORDINATOR WAS RECENTLY ABLE TO SPEAK TO THE PATIENT'S WIFE, AND WAS INFORMED THAT THE PATIENT DIED FROM A MYOCARDIAL INFARCTION. THE DEATH WAS NOT NEUROLOGICAL IN NATURE. BASED ON THIS NEW INFORMATION, THIS EVENT HAS BEEN MADE A NON-COMPLAINT, AND IS NO LONGER CONSIDERED REPORTABLE. NO FURTHER FOLLOWUP WILL BE FORTHCOMING.

    Additional Manufacturer Narrative · 1

    THE NOTIFICATION RECEIVED VIA THE (B) (4) STUDY INDICATES THAT 6 MONTHS POST-INDEX PROCEDURE, THE PATIENT EXPIRED ON (B) (6) 2009, FROM AN UNKNOWN CAUSE. THE PATIENT HAD UNDERGONE SUCCESSFUL STENTING OF THE RIGHT INTERNAL CAROTID ARTERY ON (B) (6) 2009. AT THE 30 DAY PATIENT FOLLOW-UP IN (B) (6) 2009, THE PATIENT WAS SEEN AND NO ADVERSE EVENT WAS NOTED. THE STUDY COORDINATOR AT THE SITE STATED THAT THEY WERE UNABLE TO REACH THE PATIENT FOR ONE YEAR FOLLOW-UP, AND SUBSEQUENTLY FOUND THE PATIENT'S NAME IN THE DEATH INDEX. NO INFORMATION WAS FOUND THAT THE PATIENT HAD BEEN ADMITTED TO ANY OF THE LOCAL HOSPITALS AROUND THAT TIME. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 13419273 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    THE NOTIFICATION RECEIVED VIA THE (B) (4) STUDY INDICATES THAT 6 MONTHS POST-INDEX PROCEDURE, THE PATIENT EXPIRED ON (B) (6) 2009, FROM AN UNKNOWN CAUSE. THE PATIENT HAD UNDERGONE SUCCESSFUL STENTING OF THE RIGHT INTERNAL CAROTID ARTERY ON (B) (6) 2009. AT THE 30 DAY PATIENT FOLLOWUP IN (B) (6) 2009, THE PATIENT WAS SEEN AND NO ADVERSE EVENT WAS NOTED. THE STUDY COORDINATOR AT THE SITE STATED THAT THEY WERE UNABLE TO REACH THE PATIENT FOR ONE YEAR FOLLOWUP, AND SUBSEQUENTLY FOUND THE PATIENT'S NAME IN THE DEATH INDEX. NO INFORMATION WAS FOUND THAT THE PATIENT HAD BEEN ADMITTED TO ANY OF THE LOCAL HOSPITALS AROUND THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13419273

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death 7MM ANGIOGUARD