BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1950217 · Received January 6, 2011

    Report

    Report Number
    9616099-2011-00013
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT EXPERIENCED A TIA AND HYPOTENSION DURING THE INDEX PROCEDURE. THIS IS A (B)(6) FEMALE WITH MEDICAL HISTORY INCLUDING HYPERLIPIDEMIA, CORONARY ARTERY DISEASE, HYPERTENSION. THE TARGET LESION WAS A 70-80% STENOSIS IN THE RIGHT INTERNAL CAROTID ARTERY (RICA) DISTAL TO THE BIFURCATION. THERE IS ALSO A SEVERE STENOSIS OF THE RIGHT EXTERNAL CAROTID ARTERY AT THE ORIGIN. ACCESS WAS MADE IN THE RIGHT FEMORAL ARTERY. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS NAVIGATED THROUGH THE RICA LESION WITHOUT DIFFICULTY AND DEPLOYED IN THE DISTAL ICA AT THE INTRA/EXTRACRANIAL JUNCTION. THE LESION WAS PRE-DILATED WITH A VOYAGER RX 3.5X20MM BALLOON AT 10 ATMS FOR 10 SECONDS. A PRECISE 8X40MM STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION. FOLLOWING DEPLOYMENT OF THE STENT, THE PATIENT WAS NOTED TO HAVE TRANSIENT WEAKNESS OF HER LEFT ARM. SHE WAS GIVEN 100MG NITROGLYCERIN INJECTION AND HER LEFT ARM FUNCTION RETURNED TO NORMAL. THE PATIENT ALSO DEVELOPED HYPOTENSION. THIS WAS TREATED WITH SHORT TERM MEDICATION ADMINISTRATION AND RESOLVED WITHOUT REOCCURRENCE. THE STENT WAS POST-DILATED WITH A 4X20MM AVIATOR BALLOON. THE RETRIEVAL CATHETER WAS INSERTED AND THE EPD WAS SUCCESSFULLY REMOVED FROM THE PATIENT. ANGIOGRAPHIC IMAGES WERE EXCELLENT SHOWING A LESS THAN 10% RESIDUAL STENOSIS. THE PATIENT'S NEUROLOGICAL STATUS WAS BACK TO BASELINE ON LEAVING THE ANGIO SUITE. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. TIA IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. TIA IS OFTEN ASSOCIATED WITH A TEMPORARY STOPPAGE OR SLOWING OF BLOOD FLOW TO THE CEREBRAL ARTERIES. THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY TRAVEL UPSTREAM TO THE CEREBRAL ARTERIES POTENTIALLY DISRUPTING PERFUSION. HYPOTENSION IS A WELL-KNOWN POTENTIAL ADVERSE EVENT 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. 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 OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORT # 9616099-2011-00013 AND 1016427-2011-00004.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2011-00013 AND 1016427-2011-00004.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) REGISTRY, DURING THE INDEX PROCEDURE THE PATIENT EXPERIENCED APHASIA, HEMIATAXIA ON THE LEFT. DIAGNOSIS WAS A TRANSIENT ISCHEMIC ATTACK (TIA) WHICH WAS TREATED WITH NITROGLYCERIN. THE PATIENT ALSO DEVELOPED HYPOTENSION AFTER STENT PLACEMENT WHICH WAS TREATED WITH TITRATE PHENYLEPHRINE. THE PATIENT IS A (B)(6) FEMALE WITH A 70-80% STENOSIS IN THE RIGHT INTERNAL CAROTID ARTERY (RICA) DISTAL TO THE BIFURCATION. THERE IS ALSO A SEVERE STENOSIS OF THE RIGHT EXTERNAL CAROTID ARTERY AT THE ORIGIN. ACCESS WAS MADE IN THE RIGHT FEMORAL ARTERY. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS NAVIGATED THROUGH THE RICA LESION WITHOUT DIFFICULTY AND DEPLOYED IN THE DISTAL ICA AT THE INTRA/EXTRACRANIAL JUNCTION. THE LESION WAS PRE-DILATED WITH A VOYAGER RX 3.5X20MM BALLOON AT 10ATMS FOR 10 SECONDS. A PRECISE 8X40MM STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION. FOLLOWING DEPLOYMENT OF THE STENT, THE PATIENT WAS NOTED TO HAVE TRANSIENT WEAKNESS OF HER LEFT ARM. SHE WAS GIVEN 100MG NITROGLYCERIN INJECTION AND HER LEFT ARM FUNCTION RETURNED TO NORMAL. THE PATIENT ALSO DEVELOPED HYPOTENSION. THE STENT WAS POST-DILATED WITH A 4X20MM AVIATOR BALLOON. THE RETRIEVAL CATHETER WAS INSERTED AND THE EPD WAS SUCCESSFULLY REMOVED FROM THE PATIENT. ANGIOGRAPHIC IMAGES WERE EXCELLENT SHOWING A LESS THAN 10% RESIDUAL STENOSIS. THE PATIENT NEUROLOGICAL STATUS WAS BACK TO BASELINE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    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 15242867

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R VOYAGER RX 3.5X20MM BALLOON, AVIATOR BALLOON