BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2001262 · Received February 25, 2011

    Report

    Report Number
    9616099-2011-00135
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    April 13, 2010
    Report Date
    January 31, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO FROM CRF ON 7/8/2011: IT WAS PREVIOUSLY REPORTED THAT AS A RESULT OF THE HYPOTENSION, THE PATIENT EXPERIENCED WATERSHED HYPOPERFUSION WITH THE SYMPTOM OF APHASIA. NEW INFORMATION REVEALED THAT THE PATIENT ALSO EXPERIENCED THE SYMPTOM OF BEHAVIOR CHANGE AS A RESULTED OF THE HYPOPERFUSION. SYMPTOMS RESOLVED IN LESS THAN 24 HOURS. THIS NEW INFORMATION DOES NOT CHANGE THE PREVIOUSLY REPORTED BASELINE CONCLUSION. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00135 AND 9616099-2011-00136.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED. CONCOMITANT MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, AND HEPARIN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00135 AND 9616099-2011-00136.

    Additional Manufacturer Narrative · 1

    AS REPORTED VIA THE (B)(4) REGISTRY, A PATIENT EXPERIENCED VOMITING AND HYPOTENSION THAT RESULTED IN WATERSHED HYPOPERFUSION WITH THE SYMPTOM OF APHASIA FOLLOWING THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 85% STENOSIS AT THE BIFURCATION OF THE LEFT COMMON CAROTID ARTERY. THE LESION WAS 20MM IN LENGTH, CONCENTRIC AND SEVERELY CALCIFIED. THE REFERENCE VESSEL WAS 6.0MM IN DIAMETER. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. A 6MM ANGIOGUARD RX WAS DEPLOYED BEYOND THE TARGET LESION AND A 9.0 X 40MM AND AN 8.0 X 40MM PRECISE PRO RX STENTS WERE IMPLANTED BY DIRECT STENTING WITH OVERLAP AT THE TARGET LESION. THERE WAS NO RESIDUAL STENOSIS. APPROXIMATELY THREE TO FOUR HOURS LATER, THE PATIENT EXPERIENCED NAUSEA AND VOMITING THAT RESULTED IN HYPOTENSION WITH THE SYSTOLIC BLOOD PRESSURE DROPPING FROM 175 TO 95MMHG. AS A RESULT OF THE HYPOTENSION, THE PATIENT EXPERIENCED WATERSHED HYPOPERFUSION WITH THE SYMPTOM OF APHASIA. THE HYPOTENSION WAS TREATED WITH INTRAVENOUS FLUIDS AND NEOSYNEPHRINE. THE SYMPTOMS RESOLVED FOLLOWING NORMALIZATION OF THE BLOOD PRESSURE. ACCORDING TO THE INVESTIGATOR, THE EVENTS WERE NOT RELATED TO THE PRECISE STENTS. THE PATIENT WAS DISCHARGED APPROXIMATELY FIVE DAYS AFTER THE INDEX PROCEDURE. AT THE TIME OF THE 30-DAY FOLLOW-UP VISIT, NIH STOKE SCALE SCORE AND RANKIN SCORES WERE 0. THE PATIENT'S MEDICAL HISTORY INCLUDES PREVIOUS RIGHT CAROTID ENDARTERECTOMY, HYPERLIPIDEMIA, CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION AND HYPERTENSION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. HYPOTENSION, HYPOPERFUSION AND THE RESULTANT TIA LIKE SYMPTOMS (APHASIA) ARE WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. THE HEMODYNAMIC INSTABILITY THAT OCCURS BOTH DURING AND AFTER CAROTID STENT IMPLANTATION IS INFLUENCED BY THE BARO-RECEPTORS, WHICH ARE LOCATED AT THE CAROTID BIFURCATION. THESE BARO-RECEPTORS ARE STIMULATED BY THE STRETCH OF INTERVENTIONAL BALLOONS, SDS (STENT DELIVERY SYSTEM) AND DISTAL PROTECTION DEVICES, INITIATING A REFLEX VIA THE GLOSSOPHARYNGEAL NERVE. THIS RESULTS IN A FALL IN BLOOD PRESSURE AND BRADYCARDIA. STENT PLACEMENT MAY PROMOTE PERSISTENT STIMULATION OF THESE BARO-RECEPTORS. THESE REACTIONS ARE ANTICIPATED RELATIVELY SHORT-TERM ADVERSE EVENTS ASSOCIATED WITH THE COMPRESSION OF THE BARO-RECEPTORS DURING BALLOON INFLATION, STENT IMPLANTATION AND FILTER DEVICE MANIPULATION. CERTAIN FACTORS MAY INFLUENCE THE LIKELIHOOD OF ANTICIPATED BARO-RECEPTOR REACTIONS SUCH AS ADVANCED AGE, VENTRICULAR DYSFUNCTION AND GENDER. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT, THEREFORE, NOT CORRECTIVE ACTION WILL BE TAKEN. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00135 AND 9616099-2011-00136.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) REGISTRY, A PATIENT EXPERIENCED VOMITING AND HYPOTENSION THAT RESULTED IN WATERSHED HYPOPERFUSION WITH THE SYMPTOM OF APHASIA FOLLOWING THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 85% STENOSIS AT THE BIFURCATION OF THE LEFT COMMON CAROTID ARTERY. THE LESION WAS 20MM IN LENGTH, CONCENTRIC AND SEVERELY CALCIFIED. THE REFERENCE VESSEL WAS 6.0MM IN DIAMETER. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. A 6MM ANGIOGUARD RX WAS DEPLOYED BEYOND THE TARGET LESION AND A 9.0 X 40MM AND A 8.0 X 40MM PRECISE PRO RX (LOT NUMBERS UNKNOWN) WERE IMPLANTED BY DIRECT STENTING WITH OVERLAP AT THE TARGET LESION. THERE WAS NO RESIDUAL STENOSIS. APPROXIMATELY THREE TO FOUR HOURS LATER, THE PATIENT EXPERIENCED NAUSEA AND VOMITING THAT RESULTED IN HYPOTENSION WITH THE SYSTOLIC BLOOD PRESSURE DROPPING FROM 175 TO 95MMHG. AS A RESULT OF THE HYPOTENSION, THE PATIENT EXPERIENCED WATERSHED HYPOPERFUSION WITH THE SYMPTOM OF APHASIA. THE HYPOTENSION WAS TREATED WITH INTRAVENOUS FLUIDS AND NEOSYNEPHRINE. THE SYMPTOMS RESOLVED FOLLOWING NORMALIZATION OF THE BLOOD PRESSURE. ACCORDING TO THE INVESTIGATOR, THE EVENTS WERE NOT RELATED TO THE PRECISE STENTS. THE PATIENT WAS DISCHARGED APPROXIMATELY FIVE DAYS AFTER THE INDEX PROCEDURE. AT THE TIME OF THE 30-DAY FOLLOW-UP VISIT, NIH STOKE SCALE SCORE AND RANKIN SCORES WERE 0.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 8.0 X 40MM PRECISE PRO RX