BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1850563 · Received October 1, 2010

    Report

    Report Number
    9616099-2010-00735
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    May 20, 2010
    Report Date
    June 8, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE CC HAS BEEN UPDATED TO REFLECT ADDITIONAL INFORMATION FROM THE ADJUDICATION MINUTES. THE ADJUDICATION MINUTES RECEIVED 9/3/2010 DISAGREE WITH THE PREVIOUS DIAGNOSIS OF A TIA. NEW INFORMATION NOTES THAT IMMEDIATELY POST-PROCEDURE ON (B)(6) 2010, THE PATIENT HAD HYPOTENSION WHICH WAS ASSOCIATED WITH DECREASED RESPONSIVENESS AND DIFFICULTY WITH COMMUNICATING. THERE WERE NO OTHER FOCAL DEFICITS IDENTIFIED. A HEAD CT WITHOUT CONTRAST WAS PERFORMED. THE RESULTS REVEALED NO ACUTE HEMORRHAGE OR INFARCT. THE HYPOTENSION WAS TREATED WITH A COMBINATION OF IV FLUIDS AND A VASOPRESSOR INFUSION. THE NEUROLOGICAL SYMPTOMS SUBSEQUENTLY RESOLVED. PREVIOUSLY, IT WAS REPORTED THAT THIS EVENT OCCURRED DURING THE PROCEDURE WHILE BOTH THE ANGIOGUARD AND THE PRECISE WERE IN PLACE. ON (B)(6) 2010, THE PATIENT WAS OBSERVED TO HAVE A NEW RIGHT PRONATOR DRIFT AND THERE WAS POSSIBLY RIGHT-SIDED NEGLECT. NEUROLOGY WAS RE-CONSULTED. THE CLINICAL IMPRESSION WAS THAT THE RIGHT PRONATOR DRIFT WAS LIKELY SECONDARY TO MUSCULOSKELETAL DISEASE; THE PAIN SECONDARY TO DEGENERATIVE ARTHRITIS AND THAT HER COGNITIVE DECLINE WAS LIKELY SECONDARY TO AN UNDERLYING DEMENTIA. THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY WITH AN 80% LESION IN THE LEFT COMMON CAROTID BIFURCATION. THE LESION WAS ECCENTRIC, ULCERATED, SEVERELY CALCIFIED AND 20MM IN LENGTH. THE VESSEL WAS MODERATELY TORTUOUS AND 8MM IN DIAMETER. THE LESION WAS PRE-DILATED. AN ANGIOGUARD WAS CHOSEN FOR THE PROCEDURE AND A PRECISE STENT WAS SUCCESSFULLY IMPLANTED. THE RESIDUAL PERCENTAGE OF STENOSIS WAS 10%. THE PATIENT WAS DISCHARGED FOUR DAYS POST PROCEDURE. THE DAY OF THE INDEX PROCEDURE, THE PATIENT EXPERIENCED A NEUROLOGICAL EVENT. THE EVENT OCCURRED DURING THE INDEX PROCEDURE; WHILE THE ANGIOGUARD AND PRECISE WERE IN PLACE. THE PATIENT WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK. THE PATIENT HAD FULL RECOVERY WITH NO DEFICIT AND NO TREATMENT WAS REQUIRED. (B)(4): THE PRODUCT WAS AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND IT WAS FOUND THAT NO ISSUES WERE PRESENT DURING THE MANUFACTURING AND INSPECTION PROCESSES. HYPOTENSION, HYPOPERFUSION AND THE RESULTANT TIA 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. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    IMMEDIATELY POST PROCEDURE THE PATIENT HAD HYPOTENSION WHICH WAS ASSOCIATED WITH DECREASED RESPONSIVENESS AND DIFFICULTY WITH COMMUNICATING. THERE WERE NO OTHER FOCAL DEFICITS IDENTIFIED. A HEAD CT WITHOUT CONTRAST WAS PERFORMED. THE RESULTS REVEALED NO ACUTE HEMORRHAGE OR INFARCT. THE HYPOTENSION WAS TREATED WITH A COMBINATION OF IV FLUIDS AND A VASOPRESSOR INFUSION. THE NEUROLOGICAL SYMPTOMS SUBSEQUENTLY RESOLVED. THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY WITH AN 80% LESION IN THE LEFT COMMON CAROTID BIFURCATION. THE LESION WAS ECCENTRIC, ULCERATED, SEVERELY CALCIFIED AND 20MM IN LENGTH. THE VESSEL WAS MODERATELY TORTUOUS AND 8MM IN DIAMETER. THE LESION WAS PRE-DILATED. AN ANGIOGUARD WAS CHOSEN FOR THE PROCEDURE AND A PRECISE STENT WAS SUCCESSFULLY IMPLANTED. THE RESIDUAL PERCENTAGE OF STENOSIS WAS 10%. THE PATIENT WAS DISCHARGED FOUR DAYS POST PROCEDURE.

    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 15121403

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention