BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2053512 · Received April 13, 2011

    Report

    Report Number
    9616099-2011-00243
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 21, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT APPROXIMATELY NINE DAYS POST INDEX PROCEDURE, THIS (B)(4) STUDY PATIENT SUFFERED AN ISCHEMIC STROKE. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING HYPERLIPIDEMIA, CABG, AND CORONARY ARTERY DISEASE. THIS PATIENT MET THE HIGH RISK CRITERIA FOR CONTRALATERAL CAROTID OCCLUSION. FOR THE INDEX PROCEDURE, THE PATIENT WAS ASYMPTOMATIC WITH AN 80% STENOSIS IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THE TARGET LESION WAS ECCENTRIC, HAD MILD CALCIFICATION AND MILD VESSEL TORTUOSITY. AN 8 X 40MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED WITH NO MALFUNCTION OR ASSOCIATED MAJOR ADVERSE EVENT. THE RESIDUAL STENOSIS WAS 10%. AN ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED AND RETRIEVED. APPROXIMATELY NINE DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED REFLEX CHANGE AND RIGHT HEMIATAXIA. AN ANGIOGRAM WAS DONE AND THE STENT WAS PATENT. NEUROLOGY WAS CONSULTED, A CT SCAN WAS PERFORMED AND A HEPARIN DRIP WAS STARTED. THE EVENT HAD A SUDDEN ONSET AND THE DURATION IS UNKNOWN. THE CAUSE OF THE ISCHEMIC STROKE IS UNKNOWN. THE PATIENT RECOVERED PARTIALLY WITH MINOR RESIDUAL BEING RIGHT SIDED ARM WEAKNESS. AT THE TIME OF EVENT INVESTIGATION, THE PATIENT WAS STILL ADMITTED TO THE HOSPITAL, THE RIGHT ARM WEAKNESS IS IMPROVING, AND THE PATIENT IS WORKING WITH PHYSICAL THERAPY AND OCCUPATIONAL THERAPY. THE EVENT WAS REPORTED TO BE UNRELATED TO THE CORDIS PRODUCT AND RELATED TO THE INDEX PROCEDURE. THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. 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 15272433 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15272433. ISCHEMIC STROKE IS A WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. STROKE IS ASSOCIATED WITH A 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. IT IS UNKNOWN IF THIS PATIENT WAS MAINTAINED ON AN ANTIPLATELET REGIMEN PER IFU GUIDELINES. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT LESION AND MEDICATION REGIMEN FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PRE AND POST-PROCEDURE MEDICATIONS INCLUDE CLOPIDOGREL AND ASPIRIN.

    Description of Event or Problem · 1

    THE PATIENT WAS DISCHARGED FIFTEEN DAYS AFTER THE INDEX PROCEDURE. THE NIH STROKE SCALE SCORE WAS 12. THE STROKE SCORE WAS 4.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE NINE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT HAD AN ISCHEMIC STROKE. THE CAUSE OF THE ISCHEMIC STROKE IS UNKNOWN. THE PATIENT EXPERIENCED REFLEX CHANGE AND RIGHT HEMIATAXIA. AN ANGIOGRAM WAS DONE AND THE STENT WAS PATENT, NEUROLOGY WAS CONSULTED, A CT SCAN WAS PERFORMED AND A HEPARIN DRIP WAS STARTED. THE EVENT HAD A SUDDEN ONSET AND THE DURATION IS UNKNOWN. THE PATIENT RECOVERED PARTIALLY WITH MINOR RESIDUAL BEING RIGHT SIDED ARM WEAKNESS. AT THE TIME OF EVENT INVESTIGATION, THE PATIENT WAS STILL ADMITTED TO THE HOSPITAL, THE RIGHT ARM WEAKNESS IS IMPROVING, AND THE PATIENT IS WORKING WITH PHYSICAL THERAPY AND OCCUPATIONAL THERAPY. THE EVENT WAS REPORTED TO BE UNRELATED TO THE CORDIS PRODUCT AND RELATED TO THE INDEX PROCEDURE. FOR THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED ASYMPTOMATIC WITH AN 80% STENOSIS IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THE TARGET LESION WAS ECCENTRIC, HAD MILD CALCIFICATION AND MILD VESSEL TORTUOSITY. AN 8 X 40MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED WITH NO MALFUNCTION OR ASSOCIATED MAJOR ADVERSE EVENT. THE RESIDUAL STENOSIS WAS 10%. AN ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED AND RETRIEVED.

    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 15272433

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R| S ANGIOGUARD RX| INTRA-PROCEDURE: HEPARIN.