BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1950704 · Received January 6, 2011

    Report

    Report Number
    9616099-2011-00014
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    March 25, 2009
    Report Date
    December 7, 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

    THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2009-00564 AND 9616099-2011-00015. 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. BARO-RECEPTOR RESPONSE IS OFTEN ASSOCIATED WITH HYPOTENSION AND IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CAROTID INTERVENTIONAL PROCEDURES. 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. CLINICAL RESEARCH HAS REVEALED THAT 40% OF PATIENTS UNDERGOING CAS SUSTAINED A REACTION SECONDARY TO CAROTID BODY STIMULATION DURING BALLOON INFLATION, MOST COMMONLY SHORT-TERM HYPOTENSION WITHOUT CLINICAL SYMPTOMS, NOT ASSOCIATED TO PERIPROCEDURAL CEREBRAL COMPLICATIONS. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL, LESION AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    THE PATIENT IS A (B)(6) WOMAN WITH A HISTORY OF CONTRALATERAL CAROTID STENOSIS, CAD, DYSLIPIDEMIA, DIABETES AND HYPERTENSION. ON (B)(6) 2009, SHE UNDERWENT THE INDEX PROCEDURE WITH DELIVERY OF THE ANGIOGUARD RX ECGW, PRE-STENT BALLOON ANGIOPLASTY AND PLACEMENT OF TWO OVERLAPPING PRECISE PRO RX STENTS IN THE TARGET LEFT OSTIAL ICA. ON THE SAME DATE, THE PATIENT UNDERWENT TREATMENT IN THE CONTRALATERAL RIGHT OSTIAL ICA WITH PRE-STENT BALLOON ANGIOPLASTY AND PLACEMENT OF ONE STENT, UTILIZING DISTAL EMBOLIC PROTECTION DEVICE. POST-PROCEDURE, THE PATIENT DEVELOPED HYPOTENSION DUE TO BARORECEPTOR RESPONSE TO THE STENTS PLACEMENT AND WAS PLACED ON NEOSYNEPHRINE DRIP.

    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 14003863

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention