BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2220426 · Received August 23, 2011

    Report

    Report Number
    9616099-2011-00656
    Event Type
    Death
    Date Received
    August 23, 2011
    Date of Event
    October 10, 2009
    Report Date
    August 20, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT DIED APPROXIMATELY TWO MONTHS POST INDEX PROCEDURE OF UNKNOWN CAUSES. THIS WAS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING TIA (DATE UNKNOWN), COPD, CONGESTIVE HEART FAILURE, RENAL INSUFFICIENCY, EX-SMOKER, DIABETES, CAD, MI, PTCA, ANEMIA, LIVER TRANSPLANT AND HYPERTENSION. PRE-PROCEDURE THE (B)(6) STROKE SCALE WAS 0. THE INDEX PROCEDURE WAS PERFORMED TO TREAT THE LEFT INTERNAL CAROTID ARTERY. ONE PRECISE PRO RX WAS IMPLANTED IN THE TARGET LESION AND 0% RESIDUAL STENOSIS WAS REPORTED. THERE WAS NO REPORT OF DISSECTION. THE (B)(6) STROKE SCALE WAS 0 POST-PROCEDURE. AT THE 30 DAY FOLLOW, THERE WERE NO REPORTS OF COMPLAINTS AND THE STROKE SCALE WAS AGAIN 0. THE PATIENT WAS MAINTAINED ON AN ASA AND PLAVIX REGIMEN. ACCORDING TO THE SOCIAL SECURITY DEATH INDEX, THE PATIENT EXPIRED. THE SITE NOTED THE CAUSE OF DEATH WAS UNKNOWN. DESPITE FURTHER INQUIRIES, THERE HAS BEEN NO MORE INFORMATION TO DATE. THIS EVENT WILL BE CAPTURED AS RELATED TO THE STUDY DEVICE AND NEUROLOGIC IN NATURE, ACCORDING TO THE (B)(4) ADJUDICATION MINUTES. 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 14147000 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. A PTHS (B)(4) WAS GENERATED FOR THE FOLLOW ISSUE: USAGE OF AN IFU (B)(4) REV 2 INSTEAD AN IFU (B)(4) REV 3 SINCE THIS WAS IN APPROVAL PROCESS, ACCORDING TO THE (B)(4) REV.13, WHEN A (B)(4) IS IN SIGN OFF, THE ACTUAL REVISIONS CAN BE USED, SO IN THIS CASE DOESN'T AFFECT TO THE QUALITY OF THE PRODUCT. A DHR REVIEW WAS REQUESTED TO NITINOL DEVICES & COMPONENTS (NDC), FOR PART NUMBER: (B)(4) AND STENT LOT NUMBERS 505629, 507107, 506818; AND THE RESULTS INDICATE THAT THE STENT SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. 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. THIS EVENT IS BEING ASSOCIATED WITH THE STUDY DEVICE AND RELATED TO NEUROLOGIC CAUSES. REVIEW OF THE LIMITED INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS; HOWEVER, THE PATIENT HAD MULTIPLE MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEATH.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD MALE PATIENT WITH SIGNIFICANT CARDIAC DISEASE (CHF, KNOWN SEVERE LEFT VENTRICULAR DYSFUNCTION, CARDIAC ARRHYTHMIA, CORONARY ARTERY DISEASE AND MYOCARDIAL INFARCTION) UNDERWENT SUCCESSFUL STENTING OF THE PROXIMAL LEFT INTERNAL CAROTID ON (B)(6), 2009. ON (B)(6), 2009, THE PATIENT WAS NOTED TO HAVE EXPIRED FROM CHF. THE EVENT WAS NOTED AS UNRELATED TO BOTH THE INDEX PROCEDURE AND INDEX STENT. THE CEC ADJUDICATED THE DEATH AS NEUROLOGICAL, AND DEVICE-RELATED, ON (B)(6) 2011, AS THE CAUSE OF DEATH IS SAID TO BE UNKNOWN.

    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 14147000

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death 6MM ANGIOGUARD