BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2173057 · Received July 23, 2011

    Report

    Report Number
    9616099-2011-00492
    Event Type
    Death
    Date Received
    July 23, 2011
    Date of Event
    March 20, 2009
    Report Date
    April 20, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTRAPROCEDURE: HEPARIN, PRE-PROCEDURE, POST-PROCEDURE AND DISCHARGE: ASPIRIN AND CLOPIDOGREL. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT UNDERWENT CAROTID ARTERY STENT IMPLANTATION AND APPROXIMATELY TWO MONTHS POST INDEX PROCEDURE DIED FROM NEUROLOGIC ETIOLOGY. THIS WAS AN (B)(6) PATIENT WITH MEDICAL HISTORY INCLUDING THROAT CANCER, PRIOR ENDARTERECTOMY AND SMOKING. THIS PATIENT MET THE HIGH-RISK CRITERIA OF AGE GREATER THAN (B)(6). (B)(6) 2009, THE INDEX PROCEDURE WAS PERFORMED TO TREAT AN OSTIAL LEFT INTERNAL CAROTID ARTERY LESION. THE SITE REPORTED A 0% RESIDUAL STENOSIS AND NO REPORTS OF DIFFICULTY WERE RECEIVED. THE PRE- AND POST- PROCEDURE STROKE SCALES WERE UNCHANGED. THE PATIENT WAS DISCHARGED THE NEXT DAY ON AN ANTI-PLATELET MEDICATION REGIMEN. THE 30 DAY FOLLOW UP VISIT REPORTED A STROKE SCALE OF 0. REPORT WAS RECEIVED REGARDING THE PATIENT'S DEATH IN (B)(6) 2009. AN INVESTIGATOR RECEIVED INFORMATION SUGGESTING IT WAS RELATED TO THE PATIENT'S CANCER; HOWEVER, NO DEATH CERTIFICATE OF CONFIRMATION WAS ABLE TO BE PROCURED. AS THE DEATH CANNOT BE DISASSOCIATED FROM THE DEVICE, IT HAS BEEN CAPTURED AND A NEUROLOGICALLY RELATED DEATH. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. 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 14020341 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS; HOWEVER, THE PATIENT WAS OF ADVANCED AGE AND HAD MULTIPLE MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEATH.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE (B)(4) STUDY CLINICAL EVALUATION COMMITTEE (CEC) INDICATED THAT THE CEC AGREED WITH THE CODING OF DEATH NEUROLOGIC. THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT UNDERWENT CAROTID ARTERY STENT IMPLANTATION AND APPROXIMATELY TWO MONTHS POST INDEX PROCEDURE DIED FROM NEUROLOGIC ETIOLOGY. THE INDEX PROCEDURE WAS PERFORMED TO TREAT AN OSTIAL LEFT INTERNAL CAROTID ARTERY LESION. THE SITE REPORTED A 0% RESIDUAL STENOSIS AND NO REPORTS OF DIFFICULTY WERE RECEIVED. THE PRE- AND POST- PROCEDURE STROKE SCALES WERE UNCHANGED. THE PATEINT WAS DISCHARDED THE NEXT DAY ON AN ANTI-PLATELET MEDICATION REGIMEN. THE 30 DAY FOLLOW UP VISIT REPORTED A STROKE SCALE OF 0. NO DEATH CERTIFICATE WAS ABLE TO BE PROCURED.

    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 14020341

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death ANGIOGUARD RX