BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1904873 · Received November 22, 2010

    Report

    Report Number
    9616099-2010-00874
    Event Type
    Death
    Date Received
    November 22, 2010
    Date of Event
    June 2, 2010
    Report Date
    October 28, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE NOTIFICATION RECEIVED FOR THE (B)(4) STUDY INDICATED THAT THE PATIENT EXPIRED EIGHT MONTHS AFTER THE INDEX PROCEDURE. THE CAUSE OF THE DEATH IS STILL UNKNOWN AT THIS TIME. THE PATIENT IS A (B)(6) FEMALE WHO WAS ENROLLED IN THE (B)(4) STUDY. THE TARGET LESION WAS A 90% STENOSIS OF THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS ADVANCED AND PLACED DISTAL TO THE TARGET LESION. THE LESION WAS NOT PRE-DILATED. A PRECISE SENT WAS SUCCESSFULLY PLACED IN THE LESION. THE ANGIOGUARD WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NEUROLOGICALLY INTACT WHEN REMOVED FROM THE ANGIO SUITE. THE PATIENT WAS DISCHARGED TWO DAYS POST PROCEDURE. EIGHT MONTHS AFTER THE INDEX PROCEDURE IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT HAD EXPIRED. THE SPOUSE DID NOT MENTION WHAT CAUSED THE PATIENT'S DEATH. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED AS THE ADJUDICATION NOTES HAVE BEEN REVIEWED. IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT IN (B)(6) 2010, WHILE IN A NURSING HOME, THE PATIENT FELL WHILE SITTING ON THE EDGE OF THE BED. THE PATIENT BUMPED HER HEAD ON THE HEAD BOARD DURING THE FALL. NO IMMEDIATE EFFECTS WERE NOTED; HOWEVER, BY THE NEXT MORNING THERE WAS A REPORTED DIFFERENCE IN HER EYES AND IN A LARGE BRUISE ON THE BACK OF HER HEAD AND NECK. THE PATIENT WAS RECEIVING COUMADIN AT THE TIME, AND THE INR WAS NOTED TO BE "SKY HIGH". THE PATIENT EXPIRED TWO DAYS POST FALL. THE DAUGHTER REPORTED THE CAUSE OF DEATH TO BE BRAIN BLEEDS (CEREBRAL HEMORRHAGE). THE COMBINATION OF ELEVATED INR SECONDARY TO COUMADIN THERAPY AND THE TRAUMA TO THE PATIENT'S HEAD CONTRIBUTED TO THE CEREBRAL HEMORRHAGE. THERE IS NO EVIDENCE THAT THE IMPLANTED PRECISE STENT WAS LINKED TO THE PATIENT'S FALL. BASED ON THE EVALUATION OF THE REPORTER, THE PATIENT'S KNOWN CO-MORBIDITIES, AND THE LACK OF MEDICAL EVIDENCE LINKING THE REPORTED EVENT(S) TO THE STUDY DEVICE, THE EVENT IS NOT RELATED TO THE CORDIS PRODUCT. THEREFORE, THERE IS NO COMPLAINT AGAINST A CORDIS PRODUCT, AND THIS EVENT IS NO LONGER CONSIDERED REPORTABLE. NO ADDITIONAL FOLLOW-UP WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    THE NOTIFICATION RECEIVED FOR THE (B)(4) STUDY INDICATED THAT THE PATIENT DIED EIGHT MONTHS AFTER THE INDEX PROCEDURE. THE CAUSE OF THE DEATH IS STILL UNKNOWN AT THIS TIME.THE PATIENT IS A (B)(6) FEMALE WHO WAS ENROLLED IN THE (B)(4) STUDY. THE TARGET LESION WAS A 90% STENOSIS OF THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. AN ANGIOGUARD (CAT AND LOT NUMBERS UNKNOWN) DISTAL PROTECTION DEVICE WAS ADVANCED AND PLACED DISTAL TO THE TARGET LESION. THE LESION WAS NOT PRE-DILATED. A PRECISE (PC0940RXC/ LOT UNKNOWN) STENT WAS SUCCESSFULLY PLACED IN THE LESION. THE ANGIOGUARD WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NEUROLOGICALLY INTACT WHEN REMOVED FROM THE ANGIO SUITE. THE PATIENT WAS DISCHARGED TWO DAYS POST PROCEDURE. EIGHT MONTHS AFTER THE INDEX PROCEDURE, IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT HAD EXPIRED. THE SPOUSE DID NOT MENTION WHAT CAUSED THE PATIENT'S DEATH.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death ANGIOGUARD DISTAL PROTECTION DEVICE