BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1961998 · Received January 17, 2011

    Report

    Report Number
    9616099-2011-00041
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 29, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE, THE CYPHER BX (B)(4) FAILED TO CROSS THE TARGET LESION AND THEN THE STENT HAD STRUT UPLIFT. THE PATIENT'S AGE WAS UNKNOWN, BUT WAS A FEMALE. THE TARGET LESION WAS IN THE OBTUSE MARGINAL. THE LESION WAS A RESTENOSIS DUE TO POBA. THE LESION WAS HEAVILY CALCIFIED AND THE VESSEL WAS SLIGHTLY TORTUOUS. THERE WAS 99% STENOSIS. FEMORAL APPROACH WAS CHOSEN FOR THE PROCEDURE. A GUIDING CATHETER (LAUNCHER 7F EBU3.5) WAS ENGAGED TO THE TARGET VESSEL AND A GUIDEWIRE (RUNTHROUGH) CROSSED THE TARGET LESION. PRE-DILATION WAS CONDUCTED WITH A BALLOON (I-BP22 3.0/15MM) AT 22ATM, BUT INDENTATION WAS NOT SUFFICIENT. THEREFORE, THE LESION WAS PRE-DILATED SEVERAL MORE TIMES AND SUFFICIENT INDENTATION WAS ACHIEVED. THEN A CYPHER (COMPLAINT PRODUCT: 3.5/18MM) WAS BEING DELIVERED TO THE TARGET LESION, BUT THE CYPHER BECAME STUCK AT THE PROXIMAL CIRCUMFLEX, PROXIMAL TO THE TARGET LESION. THEREFORE ROTABLATOR WAS CONDUCTED (1.5BURR) AND THE PHYSICIAN TRIED TO REDELIVER THE CYPHER BUT THE SDS DID NOT CROSS THE TARGET LESION. THE CYPHER WAS RETRIEVED FROM THE PATIENT AND THE DISTAL END OF THE STENT WAS CONFIRMED TO BE FLARED, AND SO THE PHYSICIAN STOPPED USING THE CYPHER. TO COMPLETE THE PROCEDURE, A DIFFERENT STENT (XIENCEV 3.5/23MM) WAS IMPLANTED AND POST-DILATION WITH A BALLOON (HIRYU 3.75/15MM) WAS CONDUCTED, AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS ACCIDENTALLY DISCARDED BY THE HOSPITAL. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. 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 15066439 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. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. PTHS # (B)(4) WAS GENERATED FOR LOT 15066439 TO DOCUMENT THAT VALIDATION OF THE CHANGES IN APPROVED. (B)(4). THIS NONCONFORMANCE BARES NO RELATION TO THE COMPLAINT REPORTED. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE REPORTED COMPLAINT. CYPHER (B)(4) UBD SUBASSEMBLY LOT 15066442 WAS ALSO REVIEWED AND IT WAS OBSERVED THAT (B)(4) UNITS WERE REJECTED DURING THE 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. CROSSING PROFILE INSPECTION RECORDS WERE REVIEWED AND THIS LOT WAS DEEMED ACCEPTABLE. FPI/LPI AND PROCESS MONITORING FOR CROSSING PROFILE AND STENT RETENTION TEST RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND. CRIMPING MACHINE PARAMETERS WERE REVIEWED AND WERE FOUND WITHIN SPECIFICATION DURING MANUFACTURING PROCESS OF THIS LOT. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS THE COMPLAINTS 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 EVENTS BASED ON THE LIMITED INFORMATION AVAILABLE. HOWEVER, THERE ARE POSSIBLE VESSEL CHARACTERISTICS, SPECIFICALLY THE CALCIFICATION AND DEGREE OF STENOSIS THAT MAY HAVE CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE CJS (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES ; HOWEVER IT IS SIMILAR TO THE UNITED STATES PRODUCT CXS (B)(4). THE PRODUCT WAS DISCARDED AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT'S AGE WAS UNKNOWN, BUT WAS A FEMALE. THE TARGET LESION WAS IN THE OBTUSE MARGINAL. THE LESION WAS A RESTENOSIS DUE TO POBA. THE LESION WAS HEAVILY CALCIFIED AND THE VESSEL WAS SLIGHTLY TORTUOUS. THERE WAS 99% STENOSIS. FEMORAL APPROACH WAS CHOSEN FOR THE PROCEDURE. A GUIDING CATHETER (LAUNCHER 7F EBU3.5) WAS ENGAGED TO THE TARGET VESSEL AND A GUIDEWIRE (RUNTHROUGH) CROSSED THE TARGET LESION. PRE-DILATION WAS CONDUCTED WITH A BALLOON (I-BP22 3.0/15MM) AT 22ATM, BUT INDENTATION WAS NOT SUFFICIENT. THEREFORE, THE LESION WAS PRE-DILATED SEVERAL MORE TIMES AND SUFFICIENT INDENTATION WAS ACHIEVED. THEN A CYPHER (COMPLAINT PRODUCT: 3.5/18MM) WAS BEING DELIVERED TO THE TARGET LESION, BUT THE CYPHER BECAME STUCK AT THE PROXIMAL CIRCUMFLEX, PROXIMAL TO THE TARGET LESION. THEREFORE ROTABLATOR WAS CONDUCTED (1.5BURR) AND THE PHYSICIAN TRIED TO REDELIVER THE CYPHER BUT THE SDS DID NOT CROSS THE TARGET LESION. THE CYPHER WAS RETRIEVED FROM THE PATIENT AND THE DISTAL END OF THE STENT WAS CONFIRMED TO BE FLARED, AND SO THE PHYSICIAN STOPPED USING THE CYPHER. TO COMPLETE THE PROCEDURE, A DIFFERENT STENT (XIENCEV 3.5/23MM) WAS IMPLANTED AND POST-DILATION WITH A BALLOON (HIRYU 3.75/15MM) WAS CONDUCTED, AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS ACCIDENTALLY DISCARDED BY THE HOSPITAL. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE.

    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 15066439

    Patients

    Seq Age Sex Outcome Treatment
    1 RUNTHROUGH GUIDEWIRE, LAUNCHER 7F GUIDE CATHETER