BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1648501 · Received April 1, 2010

    Report

    Report Number
    9616099-2010-00242
    Event Type
    Death
    Date Received
    April 1, 2010
    Date of Event
    September 3, 2009
    Report Date
    March 10, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT BASELINE THE PATIENT WAS SYMPTOMATIC WITH AN (B) (6) STOKE SCORE WAS 2 AND (B) (6) SCORE WAS 2. IN ADDITION THE MEDICAL HISTORY INCLUDED PRIOR (PTA) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE RIGHT AND LEFT CAROTID ARTERIES WAS INDICATED ALONG WITH STENTING OF THE LEFT CAROTID ARTERY, SEVERE PULMONARY DISEASE, CLINICAL COPD AND HISTORY OF SMOKING (>5PACK/DAY). AT INDEX PROCEDURE THE TARGET SITE WAS THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY THAT ANGIOGRAPHICALLY HAD NO BENDS, LESIONS WITHIN 5MM, THROMBUS OR VESSEL TORTUOSITY WITH >2 BENDS. THE REFERENCE VESSEL WAS 3.6MM, TOTAL STENTED AREA WAS 20MM, THERE WAS 70% STENOSIS, AND THE LESION LENGTH WAS 5.0MM. THE LESION WAS CONCENTRIC, MILD CALCIFICATION, THE ARCH TYPE WAS III, MODERATE TORTUOSITY, AND THE GEOMETRY WAS ECCENTRIC AND ULCERATED. DURING THE PROCEDURE, THE ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED AND RETRIEVED AND WITH NO TECHNICAL DIFFICULTIES, ASSOCIATED MAJOR ADVERSE EVENTS, OR DEBRIS IN THE FILTER UPON REMOVAL. THE PRECISE PRO RX US CAROTID SYST ((B) (4)) WAS PLACED WITHOUT DOCUMENTED PREDILATION. IT WAS INDICATED THAT THERE WERE NO MALFUNCTIONS OR MAJOR ADVERSE EVENTS AND THE TARGET SITE WAS NOT RESISTANT TO PTA. REVASCULARIZATION WAS NOT PLANNED. THE FINAL TARGET LESION PERCENTAGE OF STENOSIS WAS 0%. THERE WERE NO NEUROLOGICAL DEFICITS WHEN THE PATIENT LEFT THE ANGIOGRAPHY SUITE AND NO FURTHER INTERVENTION OR TREATMENT WAS REQUIRED. PRE-PROCEDURE THE PATIENT WAS GIVEN CLOPIDOGREL. DURING THE PROCEDURE, THE PATIENT WAS GIVEN HEPARIN AND TICLOPIDINE. AT DISCHARGED THE (B) (6) SCORE WAS 2. MEDICATION CONSISTED OF CLOPIDOGREL AND ASPIRIN. NO MAJOR ADVERSE EVENTS WERE REPORTED. 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 14014733 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. AN INVESTIGATION WAS REQUESTED TO NITINOL DEVICES AND COMPONENTS (NDC) FOR REVIEW OF THE SUBCOMPONENT STENT MANUFACTURING DOCUMENTS AND THE RESULTS INDICATE THAT ALL STENTS SHIPPED MET SPECIFIED RELEASE REQUIREMENTS. THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTION ACTIONS WILL BE TAKEN. THE CAUSE OF THE PATIENT¿S DEATH TWO MONTHS CAROTID ARTERY STENTING IS NOT KNOWN. THE PATIENT¿S MEDICAL HISTORY PUTS HER AT INCREASED RISK FOR MAJOR ADVERSE EVENT. BASED ON THE LACK OF INFORMATION, NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE (B) (6) REGISTRY INDICATED THAT APPROXIMATELY TWO MONTHS POST INDEX PROCEDURE, THE PATIENT DIED. THE CAUSE OF THE DEATH WAS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE.

    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 14014733

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death