BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2220827 · Received August 23, 2011

    Report

    Report Number
    9616099-2011-00659
    Event Type
    Death
    Date Received
    August 23, 2011
    Date of Event
    June 4, 2010
    Report Date
    June 4, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE POST-PROCEDURE NEUROLOGICAL EXAM WAS UNCHANGED WHEN COMPARED TO BASELINE WITH AN (B)(4). STROKE SCALE SCORE OF 0 AND A RANKIN STROKE SCALE SCORE OF 0. PRE, POST-PROCEDURE AND DISCHARGE: ASPIRIN AND CLOPIDOGREL. INTRA-PROCEDURE: HEPARIN. THE NOTIFICATION RECEIVED FOR THE (B)(6) STUDY INDICATED APPROXIMATELY SEVEN MONTHS AFTER THE INDEX PROCEDURE THE PATIENT EXPIRED SECONDARY TO STATUS EPILEPTICUS. IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE INDEX PROCEDURE BUT THAT IT WAS RELATED TO THE CORDIS PRODUCT. RESULTS FROM THE PATIENT'S INITIAL EEG SHOWED BILATERAL PERIODIC LATERALIZED EPILEPTIFORM DISCHARGES. SUBSEQUENT EEG SHOWED THAT SHE HAD SOME PERIODIC SHARP BIFRONTAL WITH INTERSPERSED PERIODS OF RELATIVELY NORMAL BACKGROUND READING. AN EPILEPSY SPECIALIST WAS CONSULTED WHO SUBSEQUENTLY RECOMMENDED THE PATIENT BE PLACED ON BURST SUPPRESSION. SHE DID NOT AT ANY POINT AFTER THE BURST SUPPRESSION REGAIN CONSCIOUSNESS. STATUS EPILEPTICUS IS A SERIOUS SEIZURE DISORDER IN WHICH SEIZURES DO NOT STOP. A SEIZURE IS A SUDDEN DISRUPTION OF THE BRAIN'S NORMAL ELECTRICAL ACTIVITY, WHICH CAN CAUSE A LOSS OF CONSCIOUSNESS AND MAKE THE BODY TWITCH AND JERK. GENERALIZED REFERS TO ABNORMAL EXCESSIVE CORTICAL ELECTRICAL ACTIVITY, WHILE CONVULSIVE REFERS TO THE MOTOR ACTIVITY OF A SEIZURE. RESEARCH WITH PARALYZED AND ARTIFICIALLY VENTILATED ANIMALS CONCLUDED THAT NEURONAL LOSS AFTER FOCAL OR GENERALIZED STATUS EPILEPTICUS IS LINKED TO THE ABNORMAL NEURONAL DISCHARGES AND NOT SIMPLY TO THE SYSTEMIC EFFECTS OF GCSE. THE HIPPOCAMPUS SEEMS ESPECIALLY VULNERABLE TO DAMAGE BY THIS MECHANISM. ON A NEUROCHEMICAL LEVEL, SEIZURES ARE SUSTAINED BY AN IMBALANCE OF EXCESS EXCITATION AND REDUCED INHIBITION. GLUTAMATE IS THE MOST COMMON EXCITATORY NEUROTRANSMITTER AND THE NMDA (N-METHYL-D-ASPARTATE) RECEPTOR SUBTYPE IS INVOLVED. GAMMA-AMINOBUTYRIC ACID (GABA) IS THE MOST COMMON INHIBITORY NEUROTRANSMITTER. FAILURE OF INHIBITORY PROCESSES IS INCREASINGLY THOUGHT TO BE THE MAJOR MECHANISM LEADING TO STATUS EPILEPTICUS. 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 15022722 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. HOWEVER, THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    THE NOTIFICATION RECEIVED FOR THE (B)(6) STUDY INDICATED APPROXIMATELY SEVEN MONTHS AFTER THE INDEX PROCEDURE THE PATIENT EXPIRED SECONDARY TO STATUS EPILEPTICUS. IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE INDEX PROCEDURE BUT THAT IT WAS RELATED TO THE CORDIS PRODUCT. RESULTS FROM THE PATIENT'S INITIAL EEG SHOWED BILATERAL PERIODIC LATERALIZED EPILEPTIFORM DISCHARGES. SUBSEQUENT EEG SHOWED THAT SHE HAD SOME PERIODIC SHARP BIFRONTAL WITH INTERSPERSED PERIODS OF RELATIVELY NORMAL BACKGROUND READING. AN EPILEPSY SPECIALIST WAS CONSULTED WHO SUBSEQUENTLY RECOMMENDED THE PATIENT BE PLACED ON BURST SUPPRESSION. SHE DID NOT AT ANY POINT AFTER THE BURST SUPPRESSION REGAIN CONSCIOUSNESS. DURING THE INDEX PROCEDURE AN ANGIOGUARD RX EMBOLIC PROTECTION GUIDEWIRE WAS DELIVERED TO THE TARGET VESSEL. PRE-DILATATION AND PLACEMENT OF ONE 9 X 40MM PRECISE PRO RX STENT IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) WAS PERFORMED. THE SITE REPORTED A 9% FINAL RESIDUAL STENOSIS WITH NO DISSECTION. THE PATIENT WAS DISCHARGED THREE DAYS LATER WITH NO MAJOR ADVERSE EVENT.

    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 15022722

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death ANGIOGUARD GUIDEWIRE