BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2072632 · Received April 29, 2011

    Report

    Report Number
    9616099-2011-00287
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE THE CYPHER STENT DISLODGED WHILE IN THE PATIENT. THERE ARE NO PATIENT, VESSEL OR LESION CHARACTERISTICS AVAILABLE. THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE 2.75 X 33 MM CYPHER STENT "MIGRATED" FROM THE DELIVERY SYSTEM DURING USE ON THE PATIENT. IT IS UNKNOWN HOW OR IF THE STENT WAS RETRIEVED. IT WAS NOTED THAT THERE WAS NO ADVERSE EVENT, AND NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN FORTHCOMING. THE PRODUCT HAS NOT BEEN RETURN FOR ANALYSIS. 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 15290135 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4) UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. 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 15290135. PRE-STERILE LOT 15290155 WAS REVIEWED AND (B)(4) UNITS WERE REJECTED DURING THE ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. IT WAS OBSERVED DURING REVIEW THAT NONCONFORMANCE RECORDS AND PROCESS EXCURSIONS WERE ISSUED FOR THIS LOT. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. CRIMPING MACHINE PARAMETERS WERE REVIEWED ACCORDING TO (B)(4). NO ANOMALIES WERE FOUND. CROSSING PROFILE INSPECTION AND FPI AND LPI TEST RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND. STENT RETENTION RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS THE COMPLAINT COULD NOT BE CONFIRMED. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT BASED ON THE LIMITED INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE 2.75X33MM CYPHER STENT "MIGRATED" FROM THE DELIVERY SYSTEM DURING USE ON THE PATIENT. IT WAS NOTED THAT THERE WAS NO ADVERSE EVENT, AND NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 15290135

    Patients

    Seq Age Sex Outcome Treatment
    1