BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2071761 · Received April 28, 2011

    Report

    Report Number
    9616099-2011-00283
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 31, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON LAST REPORT IT WAS INCORRECTLY INDICATED THAT THE DEVICE WAS NOT RETURNED. THE DEVICE WAS RETURNED. DURING A PCI, THE CYPHER SELECT PLUS STENT WAS "PARTLY DISMOUNTED FROM THE BALLOON BY ITSELF." IT WAS SEEN WHEN THE STENT CAME OUT FROM THE DISTAL PART OF THE CATHETER LUMEN. THE STENT WAS CHANGED TO ANOTHER CYPHER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE TARGET LESION WAS LOCATED IN THE LAD. THE LESION WAS CALCIFIED. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS RESISTANCE/FRICTION WHILE INSERTING THE DEVICE THROUGH THE GUIDE CATHETER. NO ATTEMPT WAS MADE TO WITHDRAW THE STENT DEPLOYMENT SYSTEM WITH THE STENT ON THE BALLOON. THE SYSTEM WAS REMOVED AND REINSERTED ONE TIME. A 6F VISTA GUIDE CATHETER WAS USED FOR THE PROCEDURE. THE IFU INDICATES THAT SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE SDS PRE-STENT IMPLANTATION, THE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. WHEN REMOVING THE SDS AS A SINGLE UNIT, DO NOT RETRACT THE DELIVERY SYSTEM INTO THE GUIDING CATHETER OR SHEATH. FAILURE TO FOLLOW STENT/SDS REMOVAL INSTRUCTIONS AND/OR APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR SDS COMPONENTS. ONE NON-STERILE CYPHER SELECT + 2.50 X 33MM WAS RECEIVED COILED INSIDE TWO PLASTIC BAGS. THREE KINKS WERE DETECTED AT 10, 13.5 AND 22 CM FROM DISTAL END; THIS CONDITION COULD BE RELATED TO THE WAY THE UNIT WAS SENT FOR THE ANALYSIS. THE STENT WAS MOUNTED BETWEEN THE MARKER BANDS. DURING MICROSCOPIC ANALYSIS PICTURES WERE TAKEN, OMEGAS LOOKED SQUEEZED AT THE PROXIMAL AREA OF STENT. CRIMPING AND BUMPING MARKS COULD BE OBSERVED. NO OTHER DAMAGES WERE OBSERVED. CROSSING PROFILE WAS MEASURED AT THE PROXIMAL AND MIDDLE AREAS OF THE STENT AND WAS FOUND WITHIN SPECIFICATION PARAMETERS. THE DISTAL AREA WAS NOT MEASURED GIVEN THE CONDITION OF STENT (OMEGAS SQUEEZED). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE DIRECTLY CORRELATED TO THE REPORTED COMPLAINT. THE FAILURE RESISTANCE/FRICTION COULD NOT BE CONFIRMED GIVEN THE CONDITION OF THE STENT WITH THE SQUEEZED OMEGAS. THE FAILURE OFFSET/OUT OF POSITION WAS CONFIRMED SINCE THE OMEGAS WERE FOUND SQUEEZED. THE EXACT CAUSE OF THE REPORTED FAILURES COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER THERE ARE VESSEL CHARACTERISTICS (CALCIFICATION) AND PROCEDURAL FACTORS (RESISTANCE FRICTION) THAT MAY HAVE RESULTED IN THE SDS KINKS AND SQUEEZED OMEGAS IN THE STENT. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE FAILURE IS RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING A PCI, THE CYPHER SELECT PLUS STENT WAS "PARTLY DISMOUNTED FROM THE BALLOON BY ITSELF." IT WAS SEEN WHEN THE STENT CAME OUT FROM THE DISTAL PART OF THE CATHETER LUMEN. THE STENT WAS CHANGED TO ANOTHER CYPHER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE TARGET LESION WAS LOCATED IN THE LAD. THE LESION WAS CALCIFIED. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS RESISTANCE/FRICTION WHILE INSERTING THE DEVICE THROUGH THE GUIDE CATHETER. NO ATTEMPT WAS MADE TO WITHDRAW THE STENT DEPLOYMENT SYSTEM WITH THE STENT ON THE BALLOON. THE SYSTEM WAS REMOVED AND REINSERTED ONE TIME. A 6F VISTA GUIDE CATHETER WAS USED FOR THE PROCEDURE. THE IFU INDICATES THAT SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE SDS PRE-STENT IMPLANTATION, THE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. WHEN REMOVING THE SDS AS A SINGLE UNIT, DO NOT RETRACT THE DELIVERY SYSTEM INTO THE GUIDING CATHETER OR SHEATH. FAILURE TO FOLLOW STENT/SDS REMOVAL INSTRUCTIONS AND/OR APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR SDS COMPONENTS. ONE NON-STERILE CYPHER SELECT + 2.50 X 33MM WAS RECEIVED COILED INSIDE TWO PLASTIC BAGS. THREE KINKS WERE DETECTED AT 10, 13.5 AND 22 CM FROM DISTAL END; THIS CONDITION COULD BE RELATED TO THE WAY THE UNIT WAS SENT FOR THE ANALYSIS. THE STENT WAS MOUNTED BETWEEN THE MARKER BANDS. DURING MICROSCOPIC ANALYSIS PICTURES WERE TAKEN, OMEGAS LOOKED SQUEEZED AT THE PROXIMAL AREA OF STENT. CRIMPING AND BUMPING MARKS COULD BE OBSERVED. NO OTHER DAMAGES WERE OBSERVED. CROSSING PROFILE WAS MEASURED AT THE PROXIMAL AND MIDDLE AREAS OF THE STENT AND WAS FOUND WITHIN SPECIFICATION PARAMETERS. THE DISTAL AREA WAS NOT MEASURED GIVEN THE CONDITION OF STENT (OMEGAS SQUEEZED). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE DIRECTLY CORRELATED TO THE REPORTED COMPLAINT. THE FAILURE RESISTANCE/FRICTION COULD NOT BE CONFIRMED GIVEN THE CONDITION OF THE STENT WITH THE SQUEEZED OMEGAS. THE FAILURE OFFSET/OUT OF POSITION WAS CONFIRMED SINCE THE OMEGAS WERE FOUND SQUEEZED. THE EXACT CAUSE OF THE REPORTED FAILURES COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER THERE ARE VESSEL CHARACTERISTICS (CALCIFICATION) AND PROCEDURAL FACTORS (RESISTANCE FRICTION) THAT MAY HAVE RESULTED IN THE SDS KINKS AND SQUEEZED OMEGAS IN THE STENT. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE FAILURE IS RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO ACTION WILL BE TAKEN.

    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

    DURING THE PROCEDURE, THE CYPHER SELECT PLUS STENT WAS PARTLY DISMOUNTED FROM THE BALLOON BY ITSELF. IT WAS SEEN WHEN THE STENT CAME OUT FROM THE DISTAL PART OF THE CATHETER LUMEN. THE STENT WAS CHANGED TO ANOTHER CYPHER AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS.

    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 15249253

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention