BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2176725 · Received July 26, 2011

    Report

    Report Number
    9616099-2011-00502
    Event Type
    Death
    Date Received
    July 26, 2011
    Date of Event
    June 18, 2011
    Report Date
    August 24, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THREE DAYS AFTER HAVING A PRECISE STENT PLACED IN THE COMMON CAROTID BIFURCATION IN THE LEFT INTERNAL CAROTID ARTERY IT WAS REPORTED THAT THE PATIENT EXPIRED. THE MD HAS ATTEMPTED TO CONTACT THE FAMILY, BUT THEY HAVE NOT RETURNED HIS CALLS. AN AUTOPSY WAS DECLINED. 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 15374610 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 2 UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15374610. MANUFACTURING RECORDS FOR LOT 15374610 WERE REVIEWED AND PRODUCT MET ALL QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. A DHR REVIEW WAS REQUESTED TO NITINOL DEVICES & COMPONENTS (NDC), FOR PART NUMBER: (B)(4) AND STENT LOT NUMBERS 2004096, 2003786, 2003784 AND 2002638; AND THE RESULTS INDICATE THAT THE STENT SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE (B)(6) MALE PATIENT WAS PART OF THE (B)(4) STUDY. THE PATIENT RECEIVED A PRECISE STENT IN A COMON CAROTID BIFURCATION IN THE LEFT INTERNAL CAROTID. THREE DAYS AFTER THE INDEX PROCEDURE THE PATIENT DIED. NO AUTOPSY WAS PERFORMED. A CAUSE OF DEATH HAS NOT YET BEEN PROVIDED BY THE SITE.

    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 15374610

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death ANGIOGUARD DEVICE